Multiple level thresholds to modify operation of powered surgical instruments

ABSTRACT

Thresholds can be assigned for one or more parameters in connection with the operation of a surgical device. An ultimate threshold can trigger a desired action, including cessation of operations or modification of operations, if the ultimate threshold is reached, or predicted to be reached. In addition, a marginal threshold can trigger a desired action, including improving operations such as slowing operations where the value of a parameter is measured to be between the values defined by a marginal threshold and an ultimate threshold. Multiple thresholds, based on multiple parameters, can be defined, further enabling calibrated usage, such as slowing operations based on exceeding both a marginal threshold based on number of sterilization cycles and exceeding a marginal threshold based on extent to which current draw exceeds a certain value.

The present disclosure relates to surgical instruments and, in variouscircumstances, to surgical stapling and cutting instruments and staplecartridges therefor that are designed to staple and cut tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure, and the manner ofattaining them, will become more apparent and the present disclosurewill be better understood by reference to the following description ofthe present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto;

FIG. 2 is an exploded assembly view of the interchangeable shaftassembly and surgical instrument of FIG. 1;

FIG. 3 is another exploded assembly view showing portions of theinterchangeable shaft assembly and surgical instrument of FIGS. 1 and 2;

FIG. 4 is an exploded assembly view of a portion of the surgicalinstrument of FIGS. 1-3;

FIG. 5 is a cross-sectional side view of a portion of the surgicalinstrument of FIG. 4 with the firing trigger in a fully actuatedposition;

FIG. 6 is another cross-sectional view of a portion of the surgicalinstrument of FIG. 5 with the firing trigger in an unactuated position;

FIG. 7 is an exploded assembly view of one form of an interchangeableshaft assembly;

FIG. 8 is another exploded assembly view of portions of theinterchangeable shaft assembly of FIG. 7;

FIG. 9 is another exploded assembly view of portions of theinterchangeable shaft assembly of FIGS. 7 and 8;

FIG. 10 is a cross-sectional view of a portion of the interchangeableshaft assembly of FIGS. 7-9;

FIG. 11 is a perspective view of a portion of the shaft assembly ofFIGS. 7-10 with the switch drum omitted for clarity;

FIG. 12 is another perspective view of the portion of theinterchangeable shaft assembly of FIG. 11 with the switch drum mountedthereon;

FIG. 13 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anunactuated position;

FIG. 14 is a right side elevational view of the interchangeable shaftassembly and surgical instrument of FIG. 13;

FIG. 15 is a left side elevational view of the interchangeable shaftassembly and surgical instrument of FIGS. 13 and 14;

FIG. 16 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anactuated position and a firing trigger thereof in an unactuatedposition;

FIG. 17 is a right side elevational view of the interchangeable shaftassembly and surgical instrument of FIG. 16;

FIG. 18 is a left side elevational view of the interchangeable shaftassembly and surgical instrument of FIGS. 16 and 17;

FIG. 18A is a right side elevational view of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anactuated position and the firing trigger thereof in an actuatedposition;

FIG. 19 is a schematic of a system for powering down an electricalconnector of a surgical instrument handle when a shaft assembly is notcoupled thereto;

FIG. 20 is an exploded view of one aspect of an end effector of thesurgical instrument of FIG. 1;

FIGS. 21A-21B is a circuit diagram of the surgical instrument of FIG. 1spanning two drawings sheets;

FIG. 22 illustrates one instance of a power assembly comprising a usagecycle circuit configured to generate a usage cycle count of the batteryback;

FIG. 23 illustrates one aspect of a process for sequentially energizinga segmented circuit;

FIG. 24 illustrates one aspect of a power segment comprising a pluralityof daisy chained power converters;

FIG. 25 illustrates one aspect of a segmented circuit configured tomaximize power available for critical and/or power intense functions;

FIG. 26 illustrates one aspect of a power system comprising a pluralityof daisy chained power converters configured to be sequentiallyenergized;

FIG. 27 illustrates one aspect of a segmented circuit comprising anisolated control section;

FIG. 28, which is divided into FIGS. 28A and 28B, is a circuit diagramof the surgical instrument of FIG. 1;

FIG. 29 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly 14 and the powerassembly and between the handle assembly 14 and the interchangeableshaft assembly;

FIG. 30 illustrates one aspect of a process for utilizing thresholds tomodify operations of a surgical instrument;

FIG. 31 illustrates an example graph showing modification of operationsof a surgical instrument describing a linear function;

FIG. 32 illustrates an example graph showing modification of operationsof a surgical instrument describing a non-linear function;

FIG. 33 illustrates an example graph showing modification of operationsof a surgical instrument based on an expected user input parameter;

FIG. 34 illustrates an example graph showing modification of velocity ofa drive based on detection of a threshold;

FIG. 35 illustrates an example graph showing modification in connectionwith operations based on battery current based on detection of athreshold;

FIG. 36 illustrates an example graph showing modification in connectionwith operations based on battery voltage based on detection of athreshold;

FIG. 37 illustrates an example graph showing modification of knife speedbased on detection of a cycle threshold;

FIG. 38 illustrates a logic diagram of a system for evaluating sharpnessof a cutting edge of a surgical instrument according to various aspects;

FIG. 39 illustrates a logic diagram of a system for determining theforces applied against a cutting edge of a surgical instrument by asharpness testing member at various sharpness levels according tovarious aspects;

FIG. 40 illustrates a flow chart of a method for determining whether acutting edge of a surgical instrument is sufficiently sharp to transecttissue captured by the surgical instrument according to various aspects;

FIG. 41 illustrates a chart of the forces applied against a cutting edgeof a surgical instrument by a sharpness testing member at varioussharpness levels according to various embodiments; and

FIG. 42 illustrates a flow chart outlining a method for determiningwhether a cutting edge of a surgical instrument is sufficiently sharp totransect tissue captured by the surgical instrument according to variousembodiments.

DESCRIPTION

Applicant of the present application owns the following patentapplications that were filed on even date herewith and which are eachherein incorporated by reference in their respective entireties:

U.S. patent application Ser. No. ______, entitled POWERED SURGICALINSTRUMENT; Attorney Docket No. END7556USNP/140481;

U.S. patent application Ser. No. ______, entitled ADAPTIVE TISSUECOMPRESSION TECHNIQUES TO ADJUST CLOSURE RATES FOR MULTIPLE TISSUETYPES; Attorney Docket No. END7557USNP/140482;

U.S. patent application Ser. No. ______, entitled OVERLAID MULTI SENSORRADIO FREQUENCY (RF) ELECTRODE SYSTEM TO MEASURE TISSUE COMPRESSION;Attorney Docket No. END7562USNP/140487;

U.S. patent application Ser. No. ______, entitled MONITORING SPEEDCONTROL AND PRECISION INCREMENTING OF MOTOR FOR POWERED SURGICALINSTRUMENTS; Attorney Docket No. END7549USNP/140474;

U.S. patent application Ser. No. ______, entitled TIME DEPENDENTEVALUATION OF SENSOR DATA TO DETERMINE STABILITY, CREEP, ANDVISCOELASTIC ELEMENTS OF MEASURES; Attorney Docket No.END7559USNP/140484;

U.S. patent application Ser. No. ______, entitled INTERACTIVE FEEDBACKSYSTEM FOR POWERED SURGICAL INSTRUMENTS; Attorney Docket No.END7555USNP/140480;

U.S. patent application Ser. No. ______, entitled CONTROL TECHNIQUES ANDSUB-PROCESSOR CONTAINED WITHIN MODULAR SHAFT WITH SELECT CONTROLPROCESSING FROM HANDLE; Attorney Docket No. END7540USNP/140465;

U.S. patent application Ser. No. ______, entitled SMART SENSORS WITHLOCAL SIGNAL PROCESSING; Attorney Docket No. END7538USNP/140463;

U.S. patent application Ser. No. ______, entitled SURGICAL INSTRUMENTCOMPRISING A LOCKABLE BATTERY HOUSING; Attorney Docket No.END7548USNP/140473;

U.S. patent application Ser. No. ______, entitled SYSTEM FOR DETECTINGTHE MIS-INSERTION OF A STAPLE CARTRIDGE INTO A SURGICAL STAPLER;Attorney Docket No. END7546USNP/140471; and

U.S. patent application Ser. No. ______, entitled SIGNAL AND POWERCOMMUNICATION SYSTEM POSITIONED ON A ROTATABLE SHAFT; Attorney DocketNo. END7561USNP/140486.

Applicant of the present application owns the following patentapplications that were filed on Feb. 27, 2015, and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/633,576, entitled SURGICALINSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION;U.S. patent application Ser. No. 14/633,546, entitled SURGICAL APPARATUSCONFIGURED TO ASSESS WHETHER A PERFORMANCE PARAMETER OF THE SURGICALAPPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND;U.S. patent application Ser. No. 14/633,576, entitled SURGICAL CHARGINGSYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE BATTERIES;U.S. patent application Ser. No. 14/633,566, entitled CHARGING SYSTEMTHAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY;U.S. patent application Ser. No. 14/633,555, entitled SYSTEM FORMONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED;U.S. patent application Ser. No. 14/633,542, entitled REINFORCED BATTERYFOR A SURGICAL INSTRUMENT;U.S. patent application Ser. No. 14/633,548, entitled POWER ADAPTER FORA SURGICAL INSTRUMENT;U.S. patent application Ser. No. 14/633,526, entitled ADAPTABLE SURGICALINSTRUMENT HANDLE;U.S. patent application Ser. No. 14/633,541, entitled MODULAR STAPLINGASSEMBLY; andU.S. patent application Ser. No. 14/633,562, entitled SURGICAL APPARATUSCONFIGURED TO TRACK AN END-OF-LIFE PARAMETER.

Applicant of the present application owns the following patentapplications that were filed on Dec. 18, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/574,478, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE END EFFECTOR AND MEANSFOR ADJUSTING THE FIRING STROKE OF A FIRING;

U.S. patent application Ser. No. 14/574,483, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS;

U.S. patent application Ser. No. 14/575,139, entitled DRIVE ARRANGEMENTSFOR ARTICULATABLE SURGICAL INSTRUMENTS;

U.S. patent application Ser. No. 14/575,148, entitled LOCKINGARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITH ARTICULATABLE SURGICALEND EFFECTORS;

U.S. patent application Ser. No. 14/575,130, entitled SURGICALINSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCRETENON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE;

U.S. patent application Ser. No. 14/575,143, entitled SURGICALINSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS;

U.S. patent application Ser. No. 14/575,117, entitled SURGICALINSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FIRING BEAMSUPPORT ARRANGEMENTS;

U.S. patent application Ser. No. 14/575,154, entitled SURGICALINSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED FIRING BEAMSUPPORT ARRANGEMENTS;

U.S. patent application Ser. No. 14/574,493, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING A FLEXIBLE ARTICULATION SYSTEM; and

U.S. patent application Ser. No. 14/574,500, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION SYSTEM.

Applicant of the present application owns the following patentapplications that were filed on Mar. 1, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 13/782,295, entitled ARTICULATABLESURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR SIGNAL COMMUNICATION,now U.S. Patent Application Publication No. 2014/0246471;

U.S. patent application Ser. No. 13/782,323, entitled ROTARY POWEREDARTICULATION JOINTS FOR SURGICAL INSTRUMENTS, now U.S. PatentApplication Publication No. 2014/0246472;

U.S. patent application Ser. No. 13/782,338, entitled THUMBWHEEL SWITCHARRANGEMENTS FOR SURGICAL INSTRUMENTS, now U.S. Patent ApplicationPublication No. 2014/0249557;

U.S. patent application Ser. No. 13/782,499, entitled ELECTROMECHANICALSURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT, now U.S. PatentApplication Publication No. 2014/0246474;

U.S. patent application Ser. No. 13/782,460, entitled MULTIPLE PROCESSORMOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS, now U.S. PatentApplication Publication No. 2014/0246478;

U.S. patent application Ser. No. 13/782,358, entitled JOYSTICK SWITCHASSEMBLIES FOR SURGICAL INSTRUMENTS, now U.S. Patent ApplicationPublication No. 2014/0246477;

U.S. patent application Ser. No. 13/782,481, entitled SENSORSTRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR, now U.S. PatentApplication Publication No. 2014/0246479;

U.S. patent application Ser. No. 13/782,518, entitled CONTROL METHODSFOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT PORTIONS, now U.S.Patent Application Publication No. 2014/0246475;

U.S. patent application Ser. No. 13/782,375, entitled ROTARY POWEREDSURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM, now U.S. PatentApplication Publication No. 2014/0246473; and

U.S. patent application Ser. No. 13/782,536, entitled SURGICALINSTRUMENT SOFT STOP, now U.S. Patent Application Publication No.2014/0246476.

Applicant of the present application also owns the following patentapplications that were filed on Mar. 14, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 13/803,097, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, now U.S. PatentApplication Publication No. 2014/0263542;

U.S. patent application Ser. No. 13/803,193, entitled CONTROLARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT, now U.S.Patent Application Publication No. 2014/0263537;

U.S. patent application Ser. No. 13/803,053, entitled INTERCHANGEABLESHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT, now U.S. PatentApplication Publication No. 2014/0263564;

U.S. patent application Ser. No. 13/803,086, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. PatentApplication Publication No. 2014/0263541;

U.S. patent application Ser. No. 13/803,210, entitled SENSORARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS,now U.S. Patent Application Publication No. 2014/0263538;

U.S. patent application Ser. No. 13/803,148, entitled MULTI-FUNCTIONMOTOR FOR A SURGICAL INSTRUMENT, now U.S. Patent Application PublicationNo. 2014/0263554;

U.S. patent application Ser. No. 13/803,066, entitled DRIVE SYSTEMLOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now U.S. PatentApplication Publication No. 2014/0263565;

U.S. patent application Ser. No. 13/803,117, entitled ARTICULATIONCONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS, now U.S. PatentApplication Publication No. 2014/0263553;

U.S. patent application Ser. No. 13/803,130, entitled DRIVE TRAINCONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now U.S. PatentApplication Publication No. 2014/0263543; and

U.S. patent application Ser. No. 13/803,159, entitled METHOD AND SYSTEMFOR OPERATING A SURGICAL INSTRUMENT, now U.S. Patent ApplicationPublication No. 2014/0277017.

Applicant of the present application also owns the following patentapplication that was filed on Mar. 7, 2014 and is herein incorporated byreference in its entirety:

U.S. patent application Ser. No. 14/200,111, entitled CONTROL SYSTEMSFOR SURGICAL INSTRUMENTS, now U.S. Patent Application Publication No.2014/0263539.

Applicant of the present application also owns the following patentapplications that were filed on Mar. 26, 2014 and are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/226,106, entitled POWER MANAGEMENTCONTROL SYSTEMS FOR SURGICAL INSTRUMENTS;

U.S. patent application Ser. No. 14/226,099, entitled STERILIZATIONVERIFICATION CIRCUIT;

U.S. patent application Ser. No. 14/226,094, entitled VERIFICATION OFNUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT;

U.S. patent application Ser. No. 14/226,117, entitled POWER MANAGEMENTTHROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL;

U.S. patent application Ser. No. 14/226,075, entitled MODULAR POWEREDSURGICAL INSTRUMENT WITH DETACHABLE SHAFT ASSEMBLIES;

U.S. patent application Ser. No. 14/226,093, entitled FEEDBACKALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS;

U.S. patent application Ser. No. 14/226,116, entitled SURGICALINSTRUMENT UTILIZING SENSOR ADAPTATION;

U.S. patent application Ser. No. 14/226,071, entitled SURGICALINSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR;

U.S. patent application Ser. No. 14/226,097, entitled SURGICALINSTRUMENT COMPRISING INTERACTIVE SYSTEMS;

U.S. patent application Ser. No. 14/226,126, entitled INTERFACE SYSTEMSFOR USE WITH SURGICAL INSTRUMENTS;

U.S. patent application Ser. No. 14/226,133, entitled MODULAR SURGICALINSTRUMENT SYSTEM;

U.S. patent application Ser. No. 14/226,081, entitled SYSTEMS ANDMETHODS FOR CONTROLLING A SEGMENTED CIRCUIT;

U.S. patent application Ser. No. 14/226,076, entitled POWER MANAGEMENTTHROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION;

U.S. patent application Ser. No. 14/226,111, entitled SURGICAL STAPLINGINSTRUMENT SYSTEM; and

U.S. patent application Ser. No. 14/226,125, entitled SURGICALINSTRUMENT COMPRISING A ROTATABLE SHAFT.

Applicant of the present application also owns the following patentapplications that were filed on Sep. 5, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/479,103, entitled CIRCUITRY ANDSENSORS FOR POWERED MEDICAL DEVICE;

U.S. patent application Ser. No. 14/479,119, entitled ADJUNCT WITHINTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION;

U.S. patent application Ser. No. 14/478,908, entitled MONITORING DEVICEDEGRADATION BASED ON COMPONENT EVALUATION;

U.S. patent application Ser. No. 14/478,895, entitled MULTIPLE SENSORSWITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT OR INTERPRETATION;

U.S. patent application Ser. No. 14/479,110, entitled USE OF POLARITY OFHALL MAGNET DETECTION TO DETECT MISLOADED CARTRIDGE;

U.S. patent application Ser. No. 14/479,098, entitled SMART CARTRIDGEWAKE UP OPERATION AND DATA RETENTION;

U.S. patent application Ser. No. 14/479,115, entitled MULTIPLE MOTORCONTROL FOR POWERED MEDICAL DEVICE; and

U.S. patent application Ser. No. 14/479,108, entitled LOCAL DISPLAY OFTISSUE PARAMETER STABILIZATION.

Applicant of the present application also owns the following patentapplications that were filed on Apr. 9, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/248,590, entitled MOTOR DRIVENSURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS, now U.S. PatentApplication Publication No. 2014/0305987;

U.S. patent application Ser. No. 14/248,581, entitled SURGICALINSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROMTHE SAME ROTATABLE OUTPUT, now U.S. Patent Application Publication No.2014/0305989;

U.S. patent application Ser. No. 14/248,595, entitled SURGICALINSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLING THE OPERATION OF THESURGICAL INSTRUMENT, now U.S. Patent Application Publication No.2014/0305988;

U.S. patent application Ser. No. 14/248,588, entitled POWERED LINEARSURGICAL STAPLER, now U.S. Patent Application Publication No.2014/0309666;

U.S. patent application Ser. No. 14/248,591, entitled TRANSMISSIONARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. Patent ApplicationPublication No. 2014/0305991;

U.S. patent application Ser. No. 14/248,584, entitled MODULAR MOTORDRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES FOR ALIGNING ROTARYDRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS, now U.S. PatentApplication Publication No. 2014/0305994;

U.S. patent application Ser. No. 14/248,587, entitled POWERED SURGICALSTAPLER, now U.S. Patent Application Publication No. 2014/0309665;

U.S. patent application Ser. No. 14/248,586, entitled DRIVE SYSTEMDECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. PatentApplication Publication No. 2014/0305990; and

U.S. patent application Ser. No. 14/248,607, entitled MODULAR MOTORDRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS, nowU.S. Patent Application Publication No. 2014/0305992.

Applicant of the present application also owns the following patentapplications that were filed on Apr. 16, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. Provisional Patent Application Ser. No. 61/812,365, entitledSURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR;

U.S. Provisional Patent Application Ser. No. 61/812,376, entitled LINEARCUTTER WITH POWER;

U.S. Provisional Patent Application Ser. No. 61/812,382, entitled LINEARCUTTER WITH MOTOR AND PISTOL GRIP;

U.S. Provisional Patent Application Ser. No. 61/812,385, entitledSURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS AND MOTORCONTROL; and

U.S. Provisional Patent Application Ser. No. 61/812,372, entitledSURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR.

The present disclosure provides an overall understanding of theprinciples of the structure, function, manufacture, and use of thedevices and methods disclosed herein. One or more examples of theseaspects are illustrated in the accompanying drawings. Those of ordinaryskill in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting examples. The features illustrated ordescribed in connection with one example may be combined with thefeatures of other examples. Such modifications and variations areintended to be included within the scope of the present disclosure.

Reference throughout the specification to “various aspects,” “someaspects,” “one aspect,” or “an aspect”, or the like, means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in various aspects,” “in some aspects,” “in one aspect”, or“in an aspect”, or the like, in places throughout the specification arenot necessarily all referring to the same aspect. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more aspects. Thus, the particularfeatures, structures, or characteristics illustrated or described inconnection with one aspect may be combined, in whole or in part, withthe features structures, or characteristics of one or more other aspectswithout limitation. Such modifications and variations are intended to beincluded within the scope of the present disclosure.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various example devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

FIGS. 1-6 depict a motor-driven surgical cutting and fasteninginstrument 10 that may or may not be reused. In the illustratedexamples, the instrument 10 includes a housing 12 that comprises ahandle assembly 14 that is configured to be grasped, manipulated andactuated by the clinician. The housing 12 is configured for operableattachment to an interchangeable shaft assembly 200 that has a surgicalend effector 300 operably coupled thereto that is configured to performone or more surgical tasks or procedures. As the present DetailedDescription proceeds, it will be understood that the various unique andnovel arrangements of the various forms of interchangeable shaftassemblies disclosed herein also may be effectively employed inconnection with robotically-controlled surgical systems. Thus, the term“housing” also may encompass a housing or similar portion of a roboticsystem that houses or otherwise operably supports at least one drivesystem that is configured to generate and apply at least one controlmotion which could be used to actuate the interchangeable shaftassemblies disclosed herein and their respective equivalents. The term“frame” may refer to a portion of a handheld surgical instrument. Theterm “frame” also may represent a portion of a robotically controlledsurgical instrument and/or a portion of the robotic system that may beused to operably control a surgical instrument. For example, theinterchangeable shaft assemblies disclosed herein may be employed withvarious robotic systems, instruments, components and methods disclosedin U.S. patent application Ser. No. 13/118,241, entitled SURGICALSTAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, nowU.S. Patent Application Publication No. US 2012/0298719. U.S. patentapplication Ser. No. 13/118,241, entitled SURGICAL STAPLING INSTRUMENTSWITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. PatentApplication Publication No. US 2012/0298719, is incorporated byreference herein in its entirety.

The housing 12 depicted in FIGS. 1-3 is shown in connection with aninterchangeable shaft assembly 200 that includes an end effector 300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 304 therein.The housing 12 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing12 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 1 illustrates the surgical instrument 10 with an interchangeableshaft assembly 200 operably coupled thereto. FIGS. 2 and 3 illustrateattachment of the interchangeable shaft assembly 200 to the housing 12or handle assembly 14. As shown in FIG. 4, the handle assembly 14 maycomprise a pair of interconnectable handle housing segments 16 and 18that may be interconnected by screws, snap features, adhesive, etc. Inthe illustrated arrangement, the handle housing segments 16, 18cooperate to form a pistol grip portion 19 that can be gripped andmanipulated by the clinician. As will be discussed in further detailbelow, the handle assembly 14 operably supports a plurality of drivesystems therein that are configured to generate and apply variouscontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto.

Referring now to FIG. 4, the handle assembly 14 may further include aframe 20 that operably supports a plurality of drive systems. Forexample, the frame 20 can operably support a “first” or closure drivesystem, generally designated as 30, which may be employed to applyclosing and opening motions to the interchangeable shaft assembly 200that is operably attached or coupled thereto. In at least one form, theclosure drive system 30 may include an actuator in the form of a closuretrigger 32 that is pivotally supported by the frame 20. Morespecifically, as illustrated in FIG. 4, the closure trigger 32 ispivotally coupled to the housing 14 by a pin 33. Such arrangementenables the closure trigger 32 to be manipulated by a clinician suchthat when the clinician grips the pistol grip portion 19 of the handleassembly 14, the closure trigger 32 may be easily pivoted from astarting or “unactuated” position to an “actuated” position and moreparticularly to a fully compressed or fully actuated position. Theclosure trigger 32 may be biased into the unactuated position by springor other biasing arrangement (not shown). In various forms, the closuredrive system 30 further includes a closure linkage assembly 34 that ispivotally coupled to the closure trigger 32. As shown in FIG. 4, theclosure linkage assembly 34 may include a first closure link 36 and asecond closure link 38 that are pivotally coupled to the closure trigger32 by a pin 35. The second closure link 38 also may be referred toherein as an “attachment member” and include a transverse attachment pin37.

Still referring to FIG. 4, it can be observed that the first closurelink 36 may have a locking wall or end 39 thereon that is configured tocooperate with a closure release assembly 60 that is pivotally coupledto the frame 20. In at least one form, the closure release assembly 60may comprise a release button assembly 62 that has a distally protrudinglocking pawl 64 formed thereon. The release button assembly 62 may bepivoted in a counterclockwise direction by a release spring (not shown).As the clinician depresses the closure trigger 32 from its unactuatedposition towards the pistol grip portion 19 of the handle assembly 14,the first closure link 36 pivots upward to a point wherein the lockingpawl 64 drops into retaining engagement with the locking wall 39 on thefirst closure link 36 thereby preventing the closure trigger 32 fromreturning to the unactuated position. See FIG. 18. Thus, the closurerelease assembly 60 serves to lock the closure trigger 32 in the fullyactuated position. When the clinician desires to unlock the closuretrigger 32 to permit it to be biased to the unactuated position, theclinician simply pivots the closure release button assembly 62 such thatthe locking pawl 64 is moved out of engagement with the locking wall 39on the first closure link 36. When the locking pawl 64 has been movedout of engagement with the first closure link 36, the closure trigger 32may pivot back to the unactuated position. Other closure trigger lockingand release arrangements also may be employed.

Further to the above, FIGS. 13-15 illustrate the closure trigger 32 inits unactuated position which is associated with an open, or unclamped,configuration of the shaft assembly 200 in which tissue can bepositioned between the jaws of the shaft assembly 200. FIGS. 16-18illustrate the closure trigger 32 in its actuated position which isassociated with a closed, or clamped, configuration of the shaftassembly 200 in which tissue is clamped between the jaws of the shaftassembly 200. Upon comparing FIGS. 14 and 17, the reader will appreciatethat, when the closure trigger 32 is moved from its unactuated position(FIG. 14) to its actuated position (FIG. 17), the closure release button62 is pivoted between a first position (FIG. 14) and a second position(FIG. 17). The rotation of the closure release button 62 can be referredto as being an upward rotation; however, at least a portion of theclosure release button 62 is being rotated toward the circuit board 100.Referring to FIG. 4, the closure release button 62 can include an arm 61extending therefrom and a magnetic element 63, such as a permanentmagnet, for example, mounted to the arm 61. When the closure releasebutton 62 is rotated from its first position to its second position, themagnetic element 63 can move toward the circuit board 100. The circuitboard 100 can include at least one sensor configured to detect themovement of the magnetic element 63. In at least one aspect, a magneticfield sensor 65, for example, can be mounted to the bottom surface ofthe circuit board 100. The magnetic field sensor 65 can be configured todetect changes in a magnetic field surrounding the magnetic field sensor65 caused by the movement of the magnetic element 63. The magnetic fieldsensor 65 can be in signal communication with a microcontroller 1500(FIG. 19), for example, which can determine whether the closure releasebutton 62 is in its first position, which is associated with theunactuated position of the closure trigger 32 and the open configurationof the end effector, its second position, which is associated with theactuated position of the closure trigger 32 and the closed configurationof the end effector, and/or any position between the first position andthe second position.

As used throughout the present disclosure, a magnetic field sensor maybe a Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance,giant magnetoresistance, magnetic tunnel junctions, giantmagnetoimpedance, magnetostrictive/piezoelectric composites,magnetodiode, magnetotransistor, fiber optic, magnetooptic, andmicroelectromechanical systems-based magnetic sensors, among others.

In at least one form, the handle assembly 14 and the frame 20 mayoperably support another drive system referred to herein as a firingdrive system 80 that is configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system may 80 also be referred to herein as a“second drive system”. The firing drive system 80 may employ an electricmotor 82, located in the pistol grip portion 19 of the handle assembly14. In various forms, the motor 82 may be a DC brushed driving motorhaving a maximum rotation of, approximately, 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor 82 may be powered by a power source 90 that inone form may comprise a removable power pack 92. As shown in FIG. 4, forexample, the power pack 92 may comprise a proximal housing portion 94that is configured for attachment to a distal housing portion 96. Theproximal housing portion 94 and the distal housing portion 96 areconfigured to operably support a plurality of batteries 98 therein.Batteries 98 may each comprise, for example, a Lithium Ion (“LI”) orother suitable battery. The distal housing portion 96 is configured forremovable operable attachment to a control circuit board assembly 100which is also operably coupled to the motor 82. A number of batteries 98may be connected in series may be used as the power source for thesurgical instrument 10. In addition, the power source 90 may bereplaceable and/or rechargeable.

As outlined above with respect to other various forms, the electricmotor 82 can include a rotatable shaft (not shown) that operablyinterfaces with a gear reducer assembly 84 that is mounted in meshingengagement with a with a set, or rack, of drive teeth 122 on alongitudinally-movable drive member 120. In use, a voltage polarityprovided by the power source 90 can operate the electric motor 82 in aclockwise direction wherein the voltage polarity applied to the electricmotor by the battery can be reversed in order to operate the electricmotor 82 in a counter-clockwise direction. When the electric motor 82 isrotated in one direction, the drive member 120 will be axially driven inthe distal direction “DD”. When the motor 82 is driven in the oppositerotary direction, the drive member 120 will be axially driven in aproximal direction “PD”. The handle assembly 14 can include a switchwhich can be configured to reverse the polarity applied to the electricmotor 82 by the power source 90. As with the other forms describedherein, the handle assembly 14 can also include a sensor that isconfigured to detect the position of the drive member 120 and/or thedirection in which the drive member 120 is being moved.

Actuation of the motor 82 can be controlled by a firing trigger 130 thatis pivotally supported on the handle assembly 14. The firing trigger 130may be pivoted between an unactuated position and an actuated position.The firing trigger 130 may be biased into the unactuated position by aspring 132 or other biasing arrangement such that when the clinicianreleases the firing trigger 130, it may be pivoted or otherwise returnedto the unactuated position by the spring 132 or biasing arrangement. Inat least one form, the firing trigger 130 can be positioned “outboard”of the closure trigger 32 as was discussed above. In at least one form,a firing trigger safety button 134 may be pivotally mounted to theclosure trigger 32 by pin 35. The safety button 134 may be positionedbetween the firing trigger 130 and the closure trigger 32 and have apivot arm 136 protruding therefrom. See FIG. 4. When the closure trigger32 is in the unactuated position, the safety button 134 is contained inthe handle assembly 14 where the clinician cannot readily access it andmove it between a safety position preventing actuation of the firingtrigger 130 and a firing position wherein the firing trigger 130 may befired. As the clinician depresses the closure trigger 32, the safetybutton 134 and the firing trigger 130 pivot down wherein they can thenbe manipulated by the clinician.

As discussed above, the handle assembly 14 can include a closure trigger32 and a firing trigger 130. Referring to FIGS. 14-18A, the firingtrigger 130 can be pivotably mounted to the closure trigger 32. Theclosure trigger 32 can include an arm 31 extending therefrom and thefiring trigger 130 can be pivotably mounted to the arm 31 about a pivotpin 33. When the closure trigger 32 is moved from its unactuatedposition (FIG. 14) to its actuated position (FIG. 17), the firingtrigger 130 can descend downwardly, as outlined above. After the safetybutton 134 has been moved to its firing position, referring primarily toFIG. 18A, the firing trigger 130 can be depressed to operate the motorof the surgical instrument firing system. In various instances, thehandle assembly 14 can include a tracking system, such as system 800,for example, configured to determine the position of the closure trigger32 and/or the position of the firing trigger 130. With primary referenceto FIGS. 14, 17, and 18A, the tracking system 800 can include a magneticelement, such as permanent magnet 802, for example, which is mounted toan arm 801 extending from the firing trigger 130. The tracking system800 can comprise one or more sensors, such as a first magnetic fieldsensor 803 and a second magnetic field sensor 804, for example, whichcan be configured to track the position of the magnet 802.

Upon comparing FIGS. 14 and 17, the reader will appreciate that, whenthe closure trigger 32 is moved from its unactuated position to itsactuated position, the magnet 802 can move between a first positionadjacent the first magnetic field sensor 803 and a second positionadjacent the second magnetic field sensor 804.

Upon comparing FIGS. 17 and 18A, the reader will further appreciatethat, when the firing trigger 130 is moved from an unfired position(FIG. 17) to a fired position (FIG. 18A), the magnet 802 can moverelative to the second magnetic field sensor 804. The sensors 803 and804 can track the movement of the magnet 802 and can be in signalcommunication with a microcontroller on the circuit board 100. With datafrom the first sensor 803 and/or the second sensor 804, themicrocontroller can determine the position of the magnet 802 along apredefined path and, based on that position, the microcontroller candetermine whether the closure trigger 32 is in its unactuated position,its actuated position, or a position therebetween. Similarly, with datafrom the first sensor 803 and/or the second sensor 804, themicrocontroller can determine the position of the magnet 802 along apredefined path and, based on that position, the microcontroller candetermine whether the firing trigger 130 is in its unfired position, itsfully fired position, or a position therebetween.

As indicated above, in at least one form, the longitudinally movabledrive member 120 has a rack of teeth 122 formed thereon for meshingengagement with a corresponding drive gear 86 of the gear reducerassembly 84. At least one form also includes a manually-actuatable“bailout” assembly 140 that is configured to enable the clinician tomanually retract the longitudinally movable drive member 120 should themotor 82 become disabled. The bailout assembly 140 may include a leveror bailout handle assembly 14 that is configured to be manually pivotedinto ratcheting engagement with teeth 124 also provided in the drivemember 120. Thus, the clinician can manually retract the drive member120 by using the bailout handle assembly 14 to ratchet the drive member120 in the proximal direction “PD”. U.S. Patent Application PublicationNo. US 2010/0089970, now U.S. Pat. No. 8,608,045 discloses bailoutarrangements and other components, arrangements and systems that alsomay be employed with the various instruments disclosed herein. U.S.patent application Ser. No. 12/249,117, entitled POWERED SURGICALCUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM,U.S. Patent Application Publication No. 2010/0089970, now U.S. Pat. No.8,608,045, is hereby incorporated by reference in its entirety.

Turning now to FIGS. 1 and 7, the interchangeable shaft assembly 200includes a surgical end effector 300 that comprises an elongated channel302 that is configured to operably support a staple cartridge 304therein. The end effector 300 may further include an anvil 306 that ispivotally supported relative to the elongated channel 302. Theinterchangeable shaft assembly 200 may further include an articulationjoint 270 and an articulation lock 350 (FIG. 8) which can be configuredto releasably hold the end effector 300 in a desired position relativeto a shaft axis SA-SA. Details regarding the construction and operationof the end effector 300, the articulation joint 270 and the articulationlock 350 are set forth in U.S. patent application Ser. No. 13/803,086,filed Mar. 14, 2013, entitled ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK, now U.S. Patent Application PublicationNo. 2014/0263541. The entire disclosure of U.S. patent application Ser.No. 13/803,086, filed Mar. 14, 2013, entitled ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. Patent ApplicationPublication No. 2014/0263541, is hereby incorporated by referenceherein. As shown in FIGS. 7 and 8, the interchangeable shaft assembly200 can further include a proximal housing or nozzle 201 comprised ofnozzle portions 202 and 203. The interchangeable shaft assembly 200 canfurther include a closure tube 260 which can be utilized to close and/oropen the anvil 306 of the end effector 300. Primarily referring now toFIGS. 8 and 9, the shaft assembly 200 can include a spine 210 which canbe configured to fixably support a shaft frame portion 212 of thearticulation lock 350. See FIG. 8. The spine 210 can be configured to,one, slidably support a firing member 220 therein and, two, slidablysupport the closure tube 260 which extends around the spine 210. Thespine 210 can also be configured to slidably support a proximalarticulation driver 230. The articulation driver 230 has a distal end231 that is configured to operably engage the articulation lock 350. Thearticulation lock 350 interfaces with an articulation frame 352 that isadapted to operably engage a drive pin (not shown) on the end effectorframe (not shown). As indicated above, further details regarding theoperation of the articulation lock 350 and the articulation frame may befound in U.S. patent application Ser. No. 13/803,086, now U.S. PatentApplication Publication No. 2014/0263541. In various circumstances, thespine 210 can comprise a proximal end 211 which is rotatably supportedin a chassis 240. In one arrangement, for example, the proximal end 211of the spine 210 has a thread 214 formed thereon for threaded attachmentto a spine bearing 216 configured to be supported within the chassis240. See FIG. 7. Such an arrangement facilitates rotatable attachment ofthe spine 210 to the chassis 240 such that the spine 210 may beselectively rotated about a shaft axis SA-SA relative to the chassis240.

Referring primarily to FIG. 7, the interchangeable shaft assembly 200includes a closure shuttle 250 that is slidably supported within thechassis 240 such that it may be axially moved relative thereto. As shownin FIGS. 3 and 7, the closure shuttle 250 includes a pair ofproximally-protruding hooks 252 that are configured for attachment tothe attachment pin 37 that is attached to the second closure link 38 aswill be discussed in further detail below. A proximal end 261 of theclosure tube 260 is coupled to the closure shuttle 250 for relativerotation thereto. For example, a U shaped connector 263 is inserted intoan annular slot 262 in the proximal end 261 of the closure tube 260 andis retained within vertical slots 253 in the closure shuttle 250. SeeFIG. 7. Such an arrangement serves to attach the closure tube 260 to theclosure shuttle 250 for axial travel therewith while enabling theclosure tube 260 to rotate relative to the closure shuttle 250 about theshaft axis SA-SA. A closure spring 268 is journaled on the closure tube260 and serves to bias the closure tube 260 in the proximal direction“PD” which can serve to pivot the closure trigger into the unactuatedposition when the shaft assembly is operably coupled to the handleassembly 14.

In at least one form, the interchangeable shaft assembly 200 may furtherinclude an articulation joint 270. Other interchangeable shaftassemblies, however, may not be capable of articulation. As shown inFIG. 7, for example, the articulation joint 270 includes a double pivotclosure sleeve assembly 271. According to various forms, the doublepivot closure sleeve assembly 271 includes an end effector closuresleeve assembly 272 having upper and lower distally projecting tangs273, 274. An end effector closure sleeve assembly 272 includes ahorseshoe aperture 275 and a tab 276 for engaging an opening tab on theanvil 306 in the various manners described in U.S. patent applicationSer. No. 13/803,086, filed Mar. 14, 2013, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. PatentApplication Publication No. 2014/0263541, which has been incorporated byreference herein. As described in further detail therein, the horseshoeaperture 275 and tab 276 engage a tab on the anvil when the anvil 306 isopened. An upper double pivot link 277 includes upwardly projectingdistal and proximal pivot pins that engage respectively an upper distalpin hole in the upper proximally projecting tang 273 and an upperproximal pin hole in an upper distally projecting tang 264 on theclosure tube 260. A lower double pivot link 278 includes upwardlyprojecting distal and proximal pivot pins that engage respectively alower distal pin hole in the lower proximally projecting tang 274 and alower proximal pin hole in the lower distally projecting tang 265. Seealso FIG. 8.

In use, the closure tube 260 is translated distally (direction “DD”) toclose the anvil 306, for example, in response to the actuation of theclosure trigger 32. The anvil 306 is closed by distally translating theclosure tube 260 and thus the shaft closure sleeve assembly 272, causingit to strike a proximal surface on the anvil 360 in the manner describedin the aforementioned reference U.S. patent application Ser. No.13/803,086, now U.S. Patent Application Publication No. 2014/0263541. Aswas also described in detail in that reference, the anvil 306 is openedby proximally translating the closure tube 260 and the shaft closuresleeve assembly 272, causing tab 276 and the horseshoe aperture 275 tocontact and push against the anvil tab to lift the anvil 306. In theanvil-open position, the shaft closure tube 260 is moved to its proximalposition.

As indicated above, the surgical instrument 10 may further include anarticulation lock 350 of the types and construction described in furtherdetail in U.S. patent application Ser. No. 13/803,086, now U.S. PatentApplication Publication No. 2014/0263541, which can be configured andoperated to selectively lock the end effector 300 in position. Sucharrangement enables the end effector 300 to be rotated, or articulated,relative to the shaft closure tube 260 when the articulation lock 350 isin its unlocked state. In such an unlocked state, the end effector 300can be positioned and pushed against soft tissue and/or bone, forexample, surrounding the surgical site within the patient in order tocause the end effector 300 to articulate relative to the closure tube260. The end effector 300 also may be articulated relative to theclosure tube 260 by an articulation driver 230.

As was also indicated above, the interchangeable shaft assembly 200further includes a firing member 220 that is supported for axial travelwithin the shaft spine 210. The firing member 220 includes anintermediate firing shaft portion 222 that is configured for attachmentto a distal cutting portion or knife bar 280. The firing member 220 alsomay be referred to herein as a “second shaft” and/or a “second shaftassembly”. As shown in FIGS. 8 and 9, the intermediate firing shaftportion 222 may include a longitudinal slot 223 in the distal endthereof which can be configured to receive a tab 284 on the proximal end282 of the distal knife bar 280. The longitudinal slot 223 and theproximal end 282 can be sized and configured to permit relative movementtherebetween and can comprise a slip joint 286. The slip joint 286 canpermit the intermediate firing shaft portion 222 of the firing drive 220to be moved to articulate the end effector 300 without moving, or atleast substantially moving, the knife bar 280. Once the end effector 300has been suitably oriented, the intermediate firing shaft portion 222can be advanced distally until a proximal sidewall of the longitudinalslot 223 comes into contact with the tab 284 in order to advance theknife bar 280 and fire the staple cartridge positioned within thechannel 302 As can be further seen in FIGS. 8 and 9, the shaft spine 210has an elongate opening or window 213 therein to facilitate assembly andinsertion of the intermediate firing shaft portion 222 into the shaftframe 210. Once the intermediate firing shaft portion 222 has beeninserted therein, a top frame segment 215 may be engaged with the shaftframe 212 to enclose the intermediate firing shaft portion 222 and knifebar 280 therein. Further description of the operation of the firingmember 220 may be found in U.S. patent application Ser. No. 13/803,086,now U.S. Patent Application Publication No. 2014/0263541.

Further to the above, the shaft assembly 200 can include a clutchassembly 400 which can be configured to selectively and releasablycouple the articulation driver 230 to the firing member 220. In oneform, the clutch assembly 400 includes a lock collar, or sleeve 402,positioned around the firing member 220 wherein the lock sleeve 402 canbe rotated between an engaged position in which the lock sleeve 402couples the articulation driver 360 to the firing member 220 and adisengaged position in which the articulation driver 360 is not operablycoupled to the firing member 200. When lock sleeve 402 is in its engagedposition, distal movement of the firing member 220 can move thearticulation driver 360 distally and, correspondingly, proximal movementof the firing member 220 can move the articulation driver 230proximally. When lock sleeve 402 is in its disengaged position, movementof the firing member 220 is not transmitted to the articulation driver230 and, as a result, the firing member 220 can move independently ofthe articulation driver 230. In various circumstances, the articulationdriver 230 can be held in position by the articulation lock 350 when thearticulation driver 230 is not being moved in the proximal or distaldirections by the firing member 220.

Referring primarily to FIG. 9, the lock sleeve 402 can comprise acylindrical, or an at least substantially cylindrical, body including alongitudinal aperture 403 defined therein configured to receive thefiring member 220. The lock sleeve 402 can comprisediametrically-opposed, inwardly-facing lock protrusions 404 and anoutwardly-facing lock member 406. The lock protrusions 404 can beconfigured to be selectively engaged with the firing member 220. Moreparticularly, when the lock sleeve 402 is in its engaged position, thelock protrusions 404 are positioned within a drive notch 224 defined inthe firing member 220 such that a distal pushing force and/or a proximalpulling force can be transmitted from the firing member 220 to the locksleeve 402. When the lock sleeve 402 is in its engaged position, thesecond lock member 406 is received within a drive notch 232 defined inthe articulation driver 230 such that the distal pushing force and/orthe proximal pulling force applied to the lock sleeve 402 can betransmitted to the articulation driver 230. In effect, the firing member220, the lock sleeve 402, and the articulation driver 230 will movetogether when the lock sleeve 402 is in its engaged position. On theother hand, when the lock sleeve 402 is in its disengaged position, thelock protrusions 404 may not be positioned within the drive notch 224 ofthe firing member 220 and, as a result, a distal pushing force and/or aproximal pulling force may not be transmitted from the firing member 220to the lock sleeve 402. Correspondingly, the distal pushing force and/orthe proximal pulling force may not be transmitted to the articulationdriver 230. In such circumstances, the firing member 220 can be slidproximally and/or distally relative to the lock sleeve 402 and theproximal articulation driver 230.

As shown in FIGS. 8-12, the shaft assembly 200 further includes a switchdrum 500 that is rotatably received on the closure tube 260. The switchdrum 500 comprises a hollow shaft segment 502 that has a shaft boss 504formed thereon for receive an outwardly protruding actuation pin 410therein. In various circumstances, the actuation pin 410 extends througha slot 267 into a longitudinal slot 408 provided in the lock sleeve 402to facilitate axial movement of the lock sleeve 402 when it is engagedwith the articulation driver 230. A rotary torsion spring 420 isconfigured to engage the boss 504 on the switch drum 500 and a portionof the nozzle housing 203 as shown in FIG. 10 to apply a biasing forceto the switch drum 500. The switch drum 500 can further comprise atleast partially circumferential openings 506 defined therein which,referring to FIGS. 5 and 6, can be configured to receive circumferentialmounts 204, 205 extending from the nozzle halves 202, 203 and permitrelative rotation, but not translation, between the switch drum 500 andthe proximal nozzle 201. As shown in those Figures, the mounts 204 and205 also extend through openings 266 in the closure tube 260 to beseated in recesses 211 in the shaft spine 210. However, rotation of thenozzle 201 to a point where the mounts 204, 205 reach the end of theirrespective slots 506 in the switch drum 500 will result in rotation ofthe switch drum 500 about the shaft axis SA-SA. Rotation of the switchdrum 500 will ultimately result in the rotation of eth actuation pin 410and the lock sleeve 402 between its engaged and disengaged positions.Thus, in essence, the nozzle 201 may be employed to operably engage anddisengage the articulation drive system with the firing drive system inthe various manners described in further detail in U.S. patentapplication Ser. No. 13/803,086, now U.S. Patent Application PublicationNo. 2014/0263541.

As also illustrated in FIGS. 8-12, the shaft assembly 200 can comprise aslip ring assembly 600 which can be configured to conduct electricalpower to and/or from the end effector 300 and/or communicate signals toand/or from the end effector 300, for example. The slip ring assembly600 can comprise a proximal connector flange 604 mounted to a chassisflange 242 extending from the chassis 240 and a distal connector flange601 positioned within a slot defined in the shaft housings 202, 203. Theproximal connector flange 604 can comprise a first face and the distalconnector flange 601 can comprise a second face which is positionedadjacent to and movable relative to the first face. The distal connectorflange 601 can rotate relative to the proximal connector flange 604about the shaft axis SA-SA. The proximal connector flange 604 cancomprise a plurality of concentric, or at least substantiallyconcentric, conductors 602 defined in the first face thereof. Aconnector 607 can be mounted on the proximal side of the connectorflange 601 and may have a plurality of contacts (not shown) wherein eachcontact corresponds to and is in electrical contact with one of theconductors 602. Such an arrangement permits relative rotation betweenthe proximal connector flange 604 and the distal connector flange 601while maintaining electrical contact therebetween. The proximalconnector flange 604 can include an electrical connector 606 which canplace the conductors 602 in signal communication with a shaft circuitboard 610 mounted to the shaft chassis 240, for example. In at least oneinstance, a wiring harness comprising a plurality of conductors canextend between the electrical connector 606 and the shaft circuit board610. The electrical connector 606 may extend proximally through aconnector opening 243 defined in the chassis mounting flange 242. SeeFIG. 7. U.S. patent application Ser. No. 13/800,067, entitled STAPLECARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, nowU.S. Patent Application Publication No. 2014/0263552, is incorporated byreference in its entirety. U.S. patent application Ser. No. 13/800,025,entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar.13, 2013, now U.S. Patent Application Publication No. 2014/0263551, isincorporated by reference in its entirety. Further details regardingslip ring assembly 600 may be found in U.S. patent application Ser. No.13/803,086, now U.S. Patent Application Publication No. 2014/0263541.

As discussed above, the shaft assembly 200 can include a proximalportion which is fixably mounted to the handle assembly 14 and a distalportion which is rotatable about a longitudinal axis. The rotatabledistal shaft portion can be rotated relative to the proximal portionabout the slip ring assembly 600, as discussed above. The distalconnector flange 601 of the slip ring assembly 600 can be positionedwithin the rotatable distal shaft portion. Moreover, further to theabove, the switch drum 500 can also be positioned within the rotatabledistal shaft portion. When the rotatable distal shaft portion isrotated, the distal connector flange 601 and the switch drum 500 can berotated synchronously with one another. In addition, the switch drum 500can be rotated between a first position and a second position relativeto the distal connector flange 601. When the switch drum 500 is in itsfirst position, the articulation drive system may be operably disengagedfrom the firing drive system and, thus, the operation of the firingdrive system may not articulate the end effector 300 of the shaftassembly 200. When the switch drum 500 is in its second position, thearticulation drive system may be operably engaged with the firing drivesystem and, thus, the operation of the firing drive system mayarticulate the end effector 300 of the shaft assembly 200. When theswitch drum 500 is moved between its first position and its secondposition, the switch drum 500 is moved relative to distal connectorflange 601. In various instances, the shaft assembly 200 can comprise atleast one sensor configured to detect the position of the switch drum500. Turning now to FIGS. 11 and 12, the distal connector flange 601 cancomprise a magnetic field sensor 605, for example, and the switch drum500 can comprise a magnetic element, such as permanent magnet 505, forexample. The magnetic field sensor 605 can be configured to detect theposition of the permanent magnet 505. When the switch drum 500 isrotated between its first position and its second position, thepermanent magnet 505 can move relative to the magnetic field sensor 605.In various instances, magnetic field sensor 605 can detect changes in amagnetic field created when the permanent magnet 505 is moved. Themagnetic field sensor 605 can be in signal communication with the shaftcircuit board 610 and/or the handle circuit board 100, for example.Based on the signal from the magnetic field sensor 605, amicrocontroller on the shaft circuit board 610 and/or the handle circuitboard 100 can determine whether the articulation drive system is engagedwith or disengaged from the firing drive system.

Referring again to FIGS. 3 and 7, the chassis 240 includes at least one,and preferably two, tapered attachment portions 244 formed thereon thatare adapted to be received within corresponding dovetail slots 702formed within a distal attachment flange portion 700 of the frame 20.Each dovetail slot 702 may be tapered or, stated another way, besomewhat V-shaped to seatingly receive the attachment portions 244therein. As can be further seen in FIGS. 3 and 7, a shaft attachment lug226 is formed on the proximal end of the intermediate firing shaft 222.As will be discussed in further detail below, when the interchangeableshaft assembly 200 is coupled to the handle assembly 14, the shaftattachment lug 226 is received in a firing shaft attachment cradle 126formed in the distal end 125 of the longitudinal drive member 120 asshown in FIGS. 3 and 6, for example.

Various shaft assemblies employ a latch system 710 for removablycoupling the shaft assembly 200 to the housing 12 and more specificallyto the frame 20. As shown in FIG. 7, for example, in at least one form,the latch system 710 includes a lock member or lock yoke 712 that ismovably coupled to the chassis 240. In the illustrated example, forexample, the lock yoke 712 has a U-shape with two spaced downwardlyextending legs 714. The legs 714 each have a pivot lug 716 formedthereon that are adapted to be received in corresponding holes 245formed in the chassis 240. Such arrangement facilitates pivotalattachment of the lock yoke 712 to the chassis 240. The lock yoke 712may include two proximally protruding lock lugs 714 that are configuredfor releasable engagement with corresponding lock detents or grooves 704in the distal attachment flange 700 of the frame 20. See FIG. 3. Invarious forms, the lock yoke 712 is biased in the proximal direction byspring or biasing member (not shown). Actuation of the lock yoke 712 maybe accomplished by a latch button 722 that is slidably mounted on alatch actuator assembly 720 that is mounted to the chassis 240. Thelatch button 722 may be biased in a proximal direction relative to thelock yoke 712. As will be discussed in further detail below, the lockyoke 712 may be moved to an unlocked position by biasing the latchbutton the in distal direction which also causes the lock yoke 712 topivot out of retaining engagement with the distal attachment flange 700of the frame 20. When the lock yoke 712 is in “retaining engagement”with the distal attachment flange 700 of the frame 20, the lock lugs 716are retainingly seated within the corresponding lock detents or grooves704 in the distal attachment flange 700.

When employing an interchangeable shaft assembly that includes an endeffector of the type described herein that is adapted to cut and fastentissue, as well as other types of end effectors, it may be desirable toprevent inadvertent detachment of the interchangeable shaft assemblyfrom the housing during actuation of the end effector. For example, inuse the clinician may actuate the closure trigger 32 to grasp andmanipulate the target tissue into a desired position. Once the targettissue is positioned within the end effector 300 in a desiredorientation, the clinician may then fully actuate the closure trigger 32to close the anvil 306 and clamp the target tissue in position forcutting and stapling. In that instance, the first drive system 30 hasbeen fully actuated. After the target tissue has been clamped in the endeffector 300, it may be desirable to prevent the inadvertent detachmentof the shaft assembly 200 from the housing 12. One form of the latchsystem 710 is configured to prevent such inadvertent detachment.

As can be most particularly seen in FIG. 7, the lock yoke 712 includesat least one and preferably two lock hooks 718 that are adapted tocontact corresponding lock lug portions 256 that are formed on theclosure shuttle 250. Referring to FIGS. 13-15, when the closure shuttle250 is in an unactuated position (i.e., the first drive system 30 isunactuated and the anvil 306 is open), the lock yoke 712 may be pivotedin a distal direction to unlock the interchangeable shaft assembly 200from the housing 12. When in that position, the lock hooks 718 do notcontact the lock lug portions 256 on the closure shuttle 250. However,when the closure shuttle 250 is moved to an actuated position (i.e., thefirst drive system 30 is actuated and the anvil 306 is in the closedposition), the lock yoke 712 is prevented from being pivoted to anunlocked position. See FIGS. 16-18. Stated another way, if the clinicianwere to attempt to pivot the lock yoke 712 to an unlocked position or,for example, the lock yoke 712 was in advertently bumped or contacted ina manner that might otherwise cause it to pivot distally, the lock hooks718 on the lock yoke 712 will contact the lock lugs 256 on the closureshuttle 250 and prevent movement of the lock yoke 712 to an unlockedposition.

Attachment of the interchangeable shaft assembly 200 to the handleassembly 14 will now be described with reference to FIG. 3. To commencethe coupling process, the clinician may position the chassis 240 of theinterchangeable shaft assembly 200 above or adjacent to the distalattachment flange 700 of the frame 20 such that the tapered attachmentportions 244 formed on the chassis 240 are aligned with the dovetailslots 702 in the frame 20. The clinician may then move the shaftassembly 200 along an installation axis IA that is perpendicular to theshaft axis SA-SA to seat the attachment portions 244 in “operableengagement” with the corresponding dovetail receiving slots 702. Indoing so, the shaft attachment lug 226 on the intermediate firing shaft222 will also be seated in the cradle 126 in the longitudinally movabledrive member 120 and the portions of pin 37 on the second closure link38 will be seated in the corresponding hooks 252 in the closure yoke250. As used herein, the term “operable engagement” in the context oftwo components means that the two components are sufficiently engagedwith each other so that upon application of an actuation motion thereto,the components may carry out their intended action, function and/orprocedure.

As discussed above, at least five systems of the interchangeable shaftassembly 200 can be operably coupled with at least five correspondingsystems of the handle assembly 14. A first system can comprise a framesystem which couples and/or aligns the frame or spine of the shaftassembly 200 with the frame 20 of the handle assembly 14. Another systemcan comprise a closure drive system 30 which can operably connect theclosure trigger 32 of the handle assembly 14 and the closure tube 260and the anvil 306 of the shaft assembly 200. As outlined above, theclosure tube attachment yoke 250 of the shaft assembly 200 can beengaged with the pin 37 on the second closure link 38. Another systemcan comprise the firing drive system 80 which can operably connect thefiring trigger 130 of the handle assembly 14 with the intermediatefiring shaft 222 of the shaft assembly 200.

As outlined above, the shaft attachment lug 226 can be operablyconnected with the cradle 126 of the longitudinal drive member 120.Another system can comprise an electrical system which can signal to acontroller in the handle assembly 14, such as microcontroller, forexample, that a shaft assembly, such as shaft assembly 200, for example,has been operably engaged with the handle assembly 14 and/or, two,conduct power and/or communication signals between the shaft assembly200 and the handle assembly 14. For instance, the shaft assembly 200 caninclude an electrical connector 1410 that is operably mounted to theshaft circuit board 610. The electrical connector 1410 is configured formating engagement with a corresponding electrical connector 1400 on thehandle control board 100. Further details regaining the circuitry andcontrol systems may be found in U.S. patent application Ser. No.13/803,086, the entire disclosure of which was previously incorporatedby reference herein. The fifth system may consist of the latching systemfor releasably locking the shaft assembly 200 to the handle assembly 14.

Referring again to FIGS. 2 and 3, the handle assembly 14 can include anelectrical connector 1400 comprising a plurality of electrical contacts.Turning now to FIG. 19, the electrical connector 1400 can comprise afirst contact 1401 a, a second contact 1401 b, a third contact 1401 c, afourth contact 1401 d, a fifth contact 1401 e, and a sixth contact 1401f, for example. While the illustrated example utilizes six contacts,other examples are envisioned which may utilize more than six contactsor less than six contacts.

As illustrated in FIG. 19, the first contact 1401 a can be in electricalcommunication with a transistor 1408, contacts 1401 b-1401 e can be inelectrical communication with a microcontroller 1500, and the sixthcontact 1401 f can be in electrical communication with a ground. Incertain circumstances, one or more of the electrical contacts 1401b-1401 e may be in electrical communication with one or more outputchannels of the microcontroller 1500 and can be energized, or have avoltage potential applied thereto, when the handle 1042 is in a poweredstate. In some circumstances, one or more of the electrical contacts1401 b-1401 e may be in electrical communication with one or more inputchannels of the microcontroller 1500 and, when the handle assembly 14 isin a powered state, the microcontroller 1500 can be configured to detectwhen a voltage potential is applied to such electrical contacts. When ashaft assembly, such as shaft assembly 200, for example, is assembled tothe handle assembly 14, the electrical contacts 1401 a-1401 f may notcommunicate with each other. When a shaft assembly is not assembled tothe handle assembly 14, however, the electrical contacts 1401 a-1401 fof the electrical connector 1400 may be exposed and, in somecircumstances, one or more of the contacts 1401 a-1401 f may beaccidentally placed in electrical communication with each other. Suchcircumstances can arise when one or more of the contacts 1401 a-1401 fcome into contact with an electrically conductive material, for example.When this occurs, the microcontroller 1500 can receive an erroneousinput and/or the shaft assembly 200 can receive an erroneous output, forexample. To address this issue, in various circumstances, the handleassembly 14 may be unpowered when a shaft assembly, such as shaftassembly 200, for example, is not attached to the handle assembly 14.

In other circumstances, the handle 1042 can be powered when a shaftassembly, such as shaft assembly 200, for example, is not attachedthereto. In such circumstances, the microcontroller 1500 can beconfigured to ignore inputs, or voltage potentials, applied to thecontacts in electrical communication with the microcontroller 1500,i.e., contacts 1401 b-1401 e, for example, until a shaft assembly isattached to the handle assembly 14. Even though the microcontroller 1500may be supplied with power to operate other functionalities of thehandle assembly 14 in such circumstances, the handle assembly 14 may bein a powered-down state. In a way, the electrical connector 1400 may bein a powered-down state as voltage potentials applied to the electricalcontacts 1401 b-1401 e may not affect the operation of the handleassembly 14. The reader will appreciate that, even though contacts 1401b-1401 e may be in a powered-down state, the electrical contacts 1401 aand 1401 f, which are not in electrical communication with themicrocontroller 1500, may or may not be in a powered-down state. Forinstance, sixth contact 1401 f may remain in electrical communicationwith a ground regardless of whether the handle assembly 14 is in apowered-up or a powered-down state.

Furthermore, the transistor 1408, and/or any other suitable arrangementof transistors, such as transistor 1410, for example, and/or switchesmay be configured to control the supply of power from a power source1404, such as a battery 90 within the handle assembly 14, for example,to the first electrical contact 1401 a regardless of whether the handleassembly 14 is in a powered-up or a powered-down state. In variouscircumstances, the shaft assembly 200, for example, can be configured tochange the state of the transistor 1408 when the shaft assembly 200 isengaged with the handle assembly 14. In certain circumstances, furtherto the below, a magnetic field sensor 1402 can be configured to switchthe state of transistor 1410 which, as a result, can switch the state oftransistor 1408 and ultimately supply power from power source 1404 tofirst contact 1401 a. In this way, both the power circuits and thesignal circuits to the connector 1400 can be powered down when a shaftassembly is not installed to the handle assembly 14 and powered up whena shaft assembly is installed to the handle assembly 14.

In various circumstances, referring again to FIG. 19, the handleassembly 14 can include the magnetic field sensor 1402, for example,which can be configured to detect a detectable element, such as amagnetic element 1407 (FIG. 3), for example, on a shaft assembly, suchas shaft assembly 200, for example, when the shaft assembly is coupledto the handle assembly 14. The magnetic field sensor 1402 can be poweredby a power source 1406, such as a battery, for example, which can, ineffect, amplify the detection signal of the magnetic field sensor 1402and communicate with an input channel of the microcontroller 1500 viathe circuit illustrated in FIG. 19. Once the microcontroller 1500 has areceived an input indicating that a shaft assembly has been at leastpartially coupled to the handle assembly 14, and that, as a result, theelectrical contacts 1401 a-1401 f are no longer exposed, themicrocontroller 1500 can enter into its normal, or powered-up, operatingstate. In such an operating state, the microcontroller 1500 willevaluate the signals transmitted to one or more of the contacts 1401b-1401 e from the shaft assembly and/or transmit signals to the shaftassembly through one or more of the contacts 1401 b-1401 e in normal usethereof. In various circumstances, the shaft assembly 200 may have to befully seated before the magnetic field sensor 1402 can detect themagnetic element 1407. While a magnetic field sensor 1402 can beutilized to detect the presence of the shaft assembly 200, any suitablesystem of sensors and/or switches can be utilized to detect whether ashaft assembly has been assembled to the handle assembly 14, forexample. In this way, further to the above, both the power circuits andthe signal circuits to the connector 1400 can be powered down when ashaft assembly is not installed to the handle assembly 14 and powered upwhen a shaft assembly is installed to the handle assembly 14.

In various examples, as may be used throughout the present disclosure,any suitable magnetic field sensor may be employed to detect whether ashaft assembly has been assembled to the handle assembly 14, forexample. For example, the technologies used for magnetic field sensinginclude Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance,giant magnetoresistance, magnetic tunnel junctions, giantmagnetoimpedance, magnetostrictive/piezoelectric composites,magnetodiode, magnetotransistor, fiber optic, magnetooptic, andmicroelectromechanical systems-based magnetic sensors, among others.

Referring to FIG. 19, the microcontroller 1500 may generally comprise amicroprocessor (“processor”) and one or more memory units operationallycoupled to the processor. By executing instruction code stored in thememory, the processor may control various components of the surgicalinstrument, such as the motor, various drive systems, and/or a userdisplay, for example. The microcontroller 1500 may be implemented usingintegrated and/or discrete hardware elements, software elements, and/ora combination of both. Examples of integrated hardware elements mayinclude processors, microprocessors, microcontrollers, integratedcircuits, application specific integrated circuits (ASIC), programmablelogic devices (PLD), digital signal processors (DSP), field programmablegate arrays (FPGA), logic gates, registers, semiconductor devices,chips, microchips, chip sets, microcontrollers, system-on-chip (SoC),and/or system-in-package (SIP). Examples of discrete hardware elementsmay include circuits and/or circuit elements such as logic gates, fieldeffect transistors, bipolar transistors, resistors, capacitors,inductors, and/or relays. In certain instances, the microcontroller 1500may include a hybrid circuit comprising discrete and integrated circuitelements or components on one or more substrates, for example.

Referring to FIG. 19, the microcontroller 1500 may be an LM 4F230H5QR,available from Texas Instruments, for example. In certain instances, theTexas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QEI) analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available. Other microcontrollersmay be readily substituted for use with the present disclosure.Accordingly, the present disclosure should not be limited in thiscontext.

As discussed above, the handle assembly 14 and/or the shaft assembly 200can include systems and configurations configured to prevent, or atleast reduce the possibility of, the contacts of the handle electricalconnector 1400 and/or the contacts of the shaft electrical connector1410 from becoming shorted out when the shaft assembly 200 is notassembled, or completely assembled, to the handle assembly 14. Referringto FIG. 3, the handle electrical connector 1400 can be at leastpartially recessed within a cavity 1409 defined in the handle frame 20.The six contacts 1401 a-1401 f of the electrical connector 1400 can becompletely recessed within the cavity 1409. Such arrangements can reducethe possibility of an object accidentally contacting one or more of thecontacts 1401 a-1401 f. Similarly, the shaft electrical connector 1410can be positioned within a recess defined in the shaft chassis 240 whichcan reduce the possibility of an object accidentally contacting one ormore of the contacts 1411 a-1411 f of the shaft electrical connector1410. With regard to the particular example depicted in FIG. 3, theshaft contacts 1411 a-1411 f can comprise male contacts. In at least oneexample, each shaft contact 1411 a-1411 f can comprise a flexibleprojection extending therefrom which can be configured to engage acorresponding handle contact 1401 a-1401 f, for example. The handlecontacts 1401 a-1401 f can comprise female contacts. In at least oneexample, each handle contact 1401 a-1401 f can comprise a flat surface,for example, against which the male shaft contacts 1401 a-1401 f canwipe, or slide, against and maintain an electrically conductiveinterface therebetween. In various instances, the direction in which theshaft assembly 200 is assembled to the handle assembly 14 can beparallel to, or at least substantially parallel to, the handle contacts1401 a-1401 f such that the shaft contacts 1411 a-1411 f slide againstthe handle contacts 1401 a-1401 f when the shaft assembly 200 isassembled to the handle assembly 14. In various alternative examples,the handle contacts 1401 a-1401 f can comprise male contacts and theshaft contacts 1411 a-1411 f can comprise female contacts. In certainalternative examples, the handle contacts 1401 a-1401 f and the shaftcontacts 1411 a-1411 f can comprise any suitable arrangement ofcontacts.

In various instances, the handle assembly 14 can comprise a connectorguard configured to at least partially cover the handle electricalconnector 1400 and/or a connector guard configured to at least partiallycover the shaft electrical connector 1410. A connector guard canprevent, or at least reduce the possibility of, an object accidentallytouching the contacts of an electrical connector when the shaft assemblyis not assembled to, or only partially assembled to, the handle. Aconnector guard can be movable. For instance, the connector guard can bemoved between a guarded position in which it at least partially guards aconnector and an unguarded position in which it does not guard, or atleast guards less of, the connector. In at least one example, aconnector guard can be displaced as the shaft assembly is beingassembled to the handle. For instance, if the handle comprises a handleconnector guard, the shaft assembly can contact and displace the handleconnector guard as the shaft assembly is being assembled to the handle.Similarly, if the shaft assembly comprises a shaft connector guard, thehandle can contact and displace the shaft connector guard as the shaftassembly is being assembled to the handle. In various instances, aconnector guard can comprise a door, for example. In at least oneinstance, the door can comprise a beveled surface which, when contactedby the handle or shaft, can facilitate the displacement of the door in acertain direction. In various instances, the connector guard can betranslated and/or rotated, for example. In certain instances, aconnector guard can comprise at least one film which covers the contactsof an electrical connector. When the shaft assembly is assembled to thehandle, the film can become ruptured. In at least one instance, the malecontacts of a connector can penetrate the film before engaging thecorresponding contacts positioned underneath the film.

As described above, the surgical instrument can include a system whichcan selectively power-up, or activate, the contacts of an electricalconnector, such as the electrical connector 1400, for example. Invarious instances, the contacts can be transitioned between anunactivated condition and an activated condition. In certain instances,the contacts can be transitioned between a monitored condition, adeactivated condition, and an activated condition. For instance, themicrocontroller 1500, for example, can monitor the contacts 1401 a-1401f when a shaft assembly has not been assembled to the handle assembly 14to determine whether one or more of the contacts 1401 a-1401 f may havebeen shorted. The microcontroller 1500 can be configured to apply a lowvoltage potential to each of the contacts 1401 a-1401 f and assesswhether only a minimal resistance is present at each of the contacts.Such an operating state can comprise the monitored condition. In theevent that the resistance detected at a contact is high, or above athreshold resistance, the microcontroller 1500 can deactivate thatcontact, more than one contact, or, alternatively, all of the contacts.Such an operating state can comprise the deactivated condition. If ashaft assembly is assembled to the handle assembly 14 and it is detectedby the microcontroller 1500, as discussed above, the microcontroller1500 can increase the voltage potential to the contacts 1401 a-1401 f.Such an operating state can comprise the activated condition.

The various shaft assemblies disclosed herein may employ sensors andvarious other components that require electrical communication with thecontroller in the housing. These shaft assemblies generally areconfigured to be able to rotate relative to the housing necessitating aconnection that facilitates such electrical communication between two ormore components that may rotate relative to each other. When employingend effectors of the types disclosed herein, the connector arrangementsmust be relatively robust in nature while also being somewhat compact tofit into the shaft assembly connector portion.

Referring to FIG. 20, a non-limiting form of the end effector 300 isillustrated. As described above, the end effector 300 may include theanvil 306 and the staple cartridge 304. In this non-limiting example,the anvil 306 is coupled to an elongate channel 198. For example,apertures 199 can be defined in the elongate channel 198 which canreceive pins 152 extending from the anvil 306 and allow the anvil 306 topivot from an open position to a closed position relative to theelongate channel 198 and staple cartridge 304. In addition, FIG. 20shows a firing bar 172, configured to longitudinally translate into theend effector 300. The firing bar 172 may be constructed from one solidsection, or in various examples, may include a laminate materialcomprising, for example, a stack of steel plates. A distally projectingend of the firing bar 172 can be attached to an E-beam 178 that can,among other things, assist in spacing the anvil 306 from a staplecartridge 304 positioned in the elongate channel 198 when the anvil 306is in a closed position. The E-beam 178 can also include a sharpenedcutting edge 182 which can be used to sever tissue as the E-beam 178 isadvanced distally by the firing bar 172. In operation, the E-beam 178can also actuate, or fire, the staple cartridge 304. The staplecartridge 304 can include a molded cartridge body 194 that holds aplurality of staples 191 resting upon staple drivers 192 withinrespective upwardly open staple cavities 195. A wedge sled 190 is drivendistally by the E-beam 178, sliding upon a cartridge tray 196 that holdstogether the various components of the replaceable staple cartridge 304.The wedge sled 190 upwardly cams the staple drivers 192 to force out thestaples 191 into deforming contact with the anvil 306 while a cuttingsurface 182 of the E-beam 178 severs clamped tissue.

Further to the above, the E-beam 178 can include upper pins 180 whichengage the anvil 306 during firing. The E-beam 178 can further includemiddle pins 184 and a bottom foot 186 which can engage various portionsof the cartridge body 194, cartridge tray 196 and elongate channel 198.When a staple cartridge 304 is positioned within the elongate channel198, a slot 193 defined in the cartridge body 194 can be aligned with aslot 197 defined in the cartridge tray 196 and a slot 189 defined in theelongate channel 198. In use, the E-beam 178 can slide through thealigned slots 193, 197, and 189 wherein, as indicated in FIG. 20, thebottom foot 186 of the E-beam 178 can engage a groove running along thebottom surface of channel 198 along the length of slot 189, the middlepins 184 can engage the top surfaces of cartridge tray 196 along thelength of longitudinal slot 197, and the upper pins 180 can engage theanvil 306. In such circumstances, the E-beam 178 can space, or limit therelative movement between, the anvil 306 and the staple cartridge 304 asthe firing bar 172 is moved distally to fire the staples from the staplecartridge 304 and/or incise the tissue captured between the anvil 306and the staple cartridge 304. Thereafter, the firing bar 172 and theE-beam 178 can be retracted proximally allowing the anvil 306 to beopened to release the two stapled and severed tissue portions (notshown).

Having described a surgical instrument 10 (FIGS. 1-4) in general terms,the description now turns to a detailed description of variouselectrical/electronic components of the surgical instrument 10. Turningnow to FIGS. 21A-21B, where one example of a segmented circuit 2000comprising a plurality of circuit segments 2002 a-2002 g is illustrated.The segmented circuit 2000 comprising the plurality of circuit segments2002 a-2002 g is configured to control a powered surgical instrument,such as, for example, the surgical instrument 10 illustrated in FIGS.1-18A, without limitation. The plurality of circuit segments 2002 a-2002g is configured to control one or more operations of the poweredsurgical instrument 10. A safety processor segment 2002 a (Segment 1)comprises a safety processor 2004. A primary processor segment 2002 b(Segment 2) comprises a primary processor 2006. The safety processor2004 and/or the primary processor 2006 are configured to interact withone or more additional circuit segments 2002 c-2002 g to controloperation of the powered surgical instrument 10. The primary processor2006 comprises a plurality of inputs coupled to, for example, one ormore circuit segments 2002 c-2002 g, a battery 2008, and/or a pluralityof switches 2058 a-2070. The segmented circuit 2000 may be implementedby any suitable circuit, such as, for example, a printed circuit boardassembly (PCBA) within the powered surgical instrument 10. It should beunderstood that the term processor as used herein includes anymicroprocessor, microcontroller, or other basic computing device thatincorporates the functions of a computer's central processing unit (CPU)on an integrated circuit or at most a few integrated circuits. Theprocessor is a multipurpose, programmable device that accepts digitaldata as input, processes it according to instructions stored in itsmemory, and provides results as output. It is an example of sequentialdigital logic, as it has internal memory. Processors operate on numbersand symbols represented in the binary numeral system.

In one aspect, the main processor 2006 may be any single core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one example, the safety processor 2004 may be asafety microcontroller platform comprising two microcontroller-basedfamilies such as TMS570 and RM4x known under the trade name Hercules ARMCortex R4, also by Texas Instruments. Nevertheless, other suitablesubstitutes for microcontrollers and safety processor may be employed,without limitation. In one example, the safety processor 2004 may beconfigured specifically for IEC 61508 and ISO 26262 safety criticalapplications, among others, to provide advanced integrated safetyfeatures while delivering scalable performance, connectivity, and memoryoptions.

In certain instances, the main processor 2006 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle SRAM, internal ROM loadedwith StellarisWare® software, 2 KB EEPROM, one or more PWM modules, oneor more QEI analog, one or more 12-bit ADC with 12 analog inputchannels, among other features that are readily available for theproduct datasheet. Other processors may be readily substituted and,accordingly, the present disclosure should not be limited in thiscontext.

In one aspect, the segmented circuit 2000 comprises an accelerationsegment 2002 c (Segment 3). The acceleration segment 2002 c comprises anacceleration sensor 2022. The acceleration sensor 2022 may comprise, forexample, an accelerometer. The acceleration sensor 2022 is configured todetect movement or acceleration of the powered surgical instrument 10.In some examples, input from the acceleration sensor 2022 is used, forexample, to transition to and from a sleep mode, identify an orientationof the powered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segment2002 c is coupled to the safety processor 2004 and/or the primaryprocessor 2006.

In one aspect, the segmented circuit 2000 comprises a display segment2002 d (Segment 4). The display segment 2002 d comprises a displayconnector 2024 coupled to the primary processor 2006. The displayconnector 2024 couples the primary processor 2006 to a display 2028through one or more display driver integrated circuits 2026. The displaydriver integrated circuits 2026 may be integrated with the display 2028and/or may be located separately from the display 2028. The display 2028may comprise any suitable display, such as, for example, an organiclight-emitting diode (OLED) display, a liquid-crystal display (LCD),and/or any other suitable display. In some examples, the display segment2002 d is coupled to the safety processor 2004.

In some aspects, the segmented circuit 2000 comprises a shaft segment2002 e (Segment 5). The shaft segment 2002 e comprises one or morecontrols for a shaft 2004 coupled to the surgical instrument 10 and/orone or more controls for an end effector 2006 coupled to the shaft 2004.The shaft segment 2002 e comprises a shaft connector 2030 configured tocouple the primary processor 2006 to a shaft PCBA 2031. The shaft PCBA2031 comprises a first articulation switch 2036, a second articulationswitch 2032, and a shaft PCBA EEPROM 2034. In some examples, the shaftPCBA EEPROM 2034 comprises one or more parameters, routines, and/orprograms specific to the shaft 2004 and/or the shaft PCBA 2031. Theshaft PCBA 2031 may be coupled to the shaft 2004 and/or integral withthe surgical instrument 10. In some examples, the shaft segment 2002 ecomprises a second shaft EEPROM 2038. The second shaft EEPROM 2038comprises a plurality of algorithms, routines, parameters, and/or otherdata corresponding to one or more shafts 2004 and/or end effectors 2006which may be interfaced with the powered surgical instrument 10.

In some aspects, the segmented circuit 2000 comprises a position encodersegment 2002 f (Segment 6). The position encoder segment 2002 fcomprises one or more magnetic rotary position encoders 2040 a-2040 b.The one or more magnetic rotary position encoders 2040 a-2040 b areconfigured to identify the rotational position of a motor 2048, a shaft2004, and/or an end effector 2006 of the surgical instrument 10. In someexamples, the magnetic rotary position encoders 2040 a-2040 b may becoupled to the safety processor 2004 and/or the primary processor 2006.

In some aspects, the segmented circuit 2000 comprises a motor segment2002 g (Segment 7). The motor segment 2002 g comprises a motor 2048configured to control one or more movements of the powered surgicalinstrument 10. The motor 2048 is coupled to the primary processor 2006by an H-Bridge driver 2042 and one or more H-bridge field-effecttransistors (FETs) 2044. The H-bridge FETs 2044 are coupled to thesafety processor 2004. A motor current sensor 2046 is coupled in serieswith the motor 2048 to measure the current draw of the motor 2048. Themotor current sensor 2046 is in signal communication with the primaryprocessor 2006 and/or the safety processor 2004. In some examples, themotor 2048 is coupled to a motor electromagnetic interference (EMI)filter 2050.

In some aspects, the segmented circuit 2000 comprises a power segment2002 h (Segment 8). A battery 2008 is coupled to the safety processor2004, the primary processor 2006, and one or more of the additionalcircuit segments 2002 c-2002 g. The battery 2008 is coupled to thesegmented circuit 2000 by a battery connector 2010 and a current sensor2012. The current sensor 2012 is configured to measure the total currentdraw of the segmented circuit 2000. In some examples, one or morevoltage converters 2014 a, 2014 b, 2016 are configured to providepredetermined voltage values to one or more circuit segments 2002 a-2002g. For example, in some examples, the segmented circuit 2000 maycomprise 3.3V voltage converters 2014 a-2014 b and/or 5V voltageconverters 2016. A boost converter 2018 is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter 2018 is configured to provide additional voltageand/or current during power intensive operations and prevent brownout orlow-power conditions.

In some aspects, the safety segment 2002 a comprises a motor powerinterrupt 2020. The motor power interrupt 2020 is coupled between thepower segment 2002 h and the motor segment 2002 g. The safety segment2002 a is configured to interrupt power to the motor segment 2002 g whenan error or fault condition is detected by the safety processor 2004and/or the primary processor 2006 as discussed in more detail herein.Although the circuit segments 2002 a-2002 g are illustrated with allcomponents of the circuit segments 2002 a-2002 h located in physicalproximity, one skilled in the art will recognize that a circuit segment2002 a-2002 h may comprise components physically and/or electricallyseparate from other components of the same circuit segment 2002 a-2002g. In some examples, one or more components may be shared between two ormore circuit segments 2002 a-2002 g.

In some aspects, a plurality of switches 2056-2070 are coupled to thesafety processor 2004 and/or the primary processor 2006. The pluralityof switches 2056-2070 may be configured to control one or moreoperations of the surgical instrument 10, control one or more operationsof the segmented circuit 2000, and/or indicate a status of the surgicalinstrument 10. For example, a bail-out door switch 2056 is configured toindicate the status of a bail-out door. A plurality of articulationswitches, such as, for example, a left side articulation left switch2058 a, a left side articulation right switch 2060 a, a left sidearticulation center switch 2062 a, a right side articulation left switch2058 b, a right side articulation right switch 2060 b, and a right sidearticulation center switch 2062 b are configured to control articulationof a shaft 2004 and/or an end effector 2006. A left side reverse switch2064 a and a right side reverse switch 2064 b are coupled to the primaryprocessor 2006. In some examples, the left side switches comprising theleft side articulation left switch 2058 a, the left side articulationright switch 2060 a, the left side articulation center switch 2062 a,and the left side reverse switch 2064 a are coupled to the primaryprocessor 2006 by a left flex connector 2072 a. The right side switchescomprising the right side articulation left switch 2058 b, the rightside articulation right switch 2060 b, the right side articulationcenter switch 2062 b, and the right side reverse switch 2064 b arecoupled to the primary processor 2006 by a right flex connector 2072 b.In some examples, a firing switch 2066, a clamp release switch 2068, anda shaft engaged switch 2070 are coupled to the primary processor 2006.

In some aspects, the plurality of switches 2056-2070 may comprise, forexample, a plurality of handle controls mounted to a handle of thesurgical instrument 10, a plurality of indicator switches, and/or anycombination thereof. In various examples, the plurality of switches2056-2070 allow a surgeon to manipulate the surgical instrument, providefeedback to the segmented circuit 2000 regarding the position and/oroperation of the surgical instrument, and/or indicate unsafe operationof the surgical instrument 10. In some examples, additional or fewerswitches may be coupled to the segmented circuit 2000, one or more ofthe switches 2056-2070 may be combined into a single switch, and/orexpanded to multiple switches. For example, in one example, one or moreof the left side and/or right side articulation switches 2058 a-2064 bmay be combined into a single multi-position switch.

In one aspect, the safety processor 2004 is configured to implement awatchdog function, among other safety operations. The safety processor2004 and the primary processor 2006 of the segmented circuit 2000 are insignal communication. A microprocessor alive heartbeat signal isprovided at output 2096. The acceleration segment 2002 c comprises anaccelerometer 2022 configured to monitor movement of the surgicalinstrument 10. In various examples, the accelerometer 2022 may be asingle, double, or triple axis accelerometer. The accelerometer 2022 maybe employed to measures proper acceleration that is not necessarily thecoordinate acceleration (rate of change of velocity). Instead, theaccelerometer sees the acceleration associated with the phenomenon ofweight experienced by a test mass at rest in the frame of reference ofthe accelerometer 2022. For example, the accelerometer 2022 at rest onthe surface of the earth will measure an acceleration g=9.8 m/s²(gravity) straight upwards, due to its weight. Another type ofacceleration that accelerometer 2022 can measure is g-forceacceleration. In various other examples, the accelerometer 2022 maycomprise a single, double, or triple axis accelerometer. Further, theacceleration segment 2002 c may comprise one or more inertial sensors todetect and measure acceleration, tilt, shock, vibration, rotation, andmultiple degrees-of-freedom (DoF). A suitable inertial sensor maycomprise an accelerometer (single, double, or triple axis), amagnetometer to measure a magnetic field in space such as the earth'smagnetic field, and/or a gyroscope to measure angular velocity.

In one aspect, the safety processor 2004 is configured to implement awatchdog function with respect to one or more circuit segments 2002c-2002 h, such as, for example, the motor segment 2002 g. In thisregards, the safety processor 2004 employs the watchdog function todetect and recover from malfunctions of the primary processor 2006.During normal operation, the safety processor 2004 monitors for hardwarefaults or program errors of the primary processor 2004 and to initiatecorrective action or actions. The corrective actions may include placingthe primary processor 2006 in a safe state and restoring normal systemoperation. In one example, the safety processor 2004 is coupled to atleast a first sensor. The first sensor measures a first property of thesurgical instrument 10 (FIGS. 1-4). In some examples, the safetyprocessor 2004 is configured to compare the measured property of thesurgical instrument 10 to a predetermined value. For example, in oneexample, a motor sensor 2040 a is coupled to the safety processor 2004.The motor sensor 2040 a provides motor speed and position information tothe safety processor 2004. The safety processor 2004 monitors the motorsensor 2040 a and compares the value to a maximum speed and/or positionvalue and prevents operation of the motor 2048 above the predeterminedvalues. In some examples, the predetermined values are calculated basedon real-time speed and/or position of the motor 2048, calculated fromvalues supplied by a second motor sensor 2040 b in communication withthe primary processor 2006, and/or provided to the safety processor 2004from, for example, a memory module coupled to the safety processor 2004.

In some aspects, a second sensor is coupled to the primary processor2006. The second sensor is configured to measure the first physicalproperty. The safety processor 2004 and the primary processor 2006 areconfigured to provide a signal indicative of the value of the firstsensor and the second sensor respectively. When either the safetyprocessor 2004 or the primary processor 2006 indicates a value outsideof an acceptable range, the segmented circuit 2000 prevents operation ofat least one of the circuit segments 2002 c-2002 h, such as, forexample, the motor segment 2002 g. For example, in the exampleillustrated in FIGS. 21A-21B, the safety processor 2004 is coupled to afirst motor position sensor 2040 a and the primary processor 2006 iscoupled to a second motor position sensor 2040 b. The motor positionsensors 2040 a, 2040 b may comprise any suitable motor position sensor,such as, for example, a magnetic angle rotary input comprising a sineand cosine output. The motor position sensors 2040 a, 2040 b providerespective signals to the safety processor 2004 and the primaryprocessor 2006 indicative of the position of the motor 2048.

The safety processor 2004 and the primary processor 2006 generate anactivation signal when the values of the first motor sensor 2040 a andthe second motor sensor 2040 b are within a predetermined range. Wheneither the primary processor 2006 or the safety processor 2004 to detecta value outside of the predetermined range, the activation signal isterminated and operation of at least one circuit segment 2002 c-2002 h,such as, for example, the motor segment 2002 g, is interrupted and/orprevented. For example, in some examples, the activation signal from theprimary processor 2006 and the activation signal from the safetyprocessor 2004 are coupled to an AND gate. The AND gate is coupled to amotor power switch 2020. The AND gate maintains the motor power switch2020 in a closed, or on, position when the activation signal from boththe safety processor 2004 and the primary processor 2006 are high,indicating a value of the motor sensors 2040 a, 2040 b within thepredetermined range. When either of the motor sensors 2040 a, 2040 bdetect a value outside of the predetermined range, the activation signalfrom that motor sensor 2040 a, 2040 b is set low, and the output of theAND gate is set low, opening the motor power switch 2020. In someexamples, the value of the first sensor 2040 a and the second sensor2040 b is compared, for example, by the safety processor 2004 and/or theprimary processor 2006. When the values of the first sensor and thesecond sensor are different, the safety processor 2004 and/or theprimary processor 2006 may prevent operation of the motor segment 2002g.

In some aspects, the safety processor 2004 receives a signal indicativeof the value of the second sensor 2040 b and compares the second sensorvalue to the first sensor value. For example, in one aspect, the safetyprocessor 2004 is coupled directly to a first motor sensor 2040 a. Asecond motor sensor 2040 b is coupled to a primary processor 2006, whichprovides the second motor sensor 2040 b value to the safety processor2004, and/or coupled directly to the safety processor 2004. The safetyprocessor 2004 compares the value of the first motor sensor 2040 to thevalue of the second motor sensor 2040 b. When the safety processor 2004detects a mismatch between the first motor sensor 2040 a and the secondmotor sensor 2040 b, the safety processor 2004 may interrupt operationof the motor segment 2002 g, for example, by cutting power to the motorsegment 2002 g.

In some aspects, the safety processor 2004 and/or the primary processor2006 is coupled to a first sensor 2040 a configured to measure a firstproperty of a surgical instrument and a second sensor 2040 b configuredto measure a second property of the surgical instrument. The firstproperty and the second property comprise a predetermined relationshipwhen the surgical instrument is operating normally. The safety processor2004 monitors the first property and the second property. When a valueof the first property and/or the second property inconsistent with thepredetermined relationship is detected, a fault occurs. When a faultoccurs, the safety processor 2004 takes at least one action, such as,for example, preventing operation of at least one of the circuitsegments, executing a predetermined operation, and/or resetting theprimary processor 2006. For example, the safety processor 2004 may openthe motor power switch 2020 to cut power to the motor circuit segment2002 g when a fault is detected.

In one aspect, the safety processor 2004 is configured to execute anindependent control algorithm. In operation, the safety processor 2004monitors the segmented circuit 2000 and is configured to control and/oroverride signals from other circuit components, such as, for example,the primary processor 2006, independently. The safety processor 2004 mayexecute a preprogrammed algorithm and/or may be updated or programmed onthe fly during operation based on one or more actions and/or positionsof the surgical instrument 10. For example, in one example, the safetyprocessor 2004 is reprogrammed with new parameters and/or safetyalgorithms each time a new shaft and/or end effector is coupled to thesurgical instrument 10. In some examples, one or more safety valuesstored by the safety processor 2004 are duplicated by the primaryprocessor 2006. Two-way error detection is performed to ensure valuesand/or parameters stored by either of the processors 2004, 2006 arecorrect.

In some aspects, the safety processor 2004 and the primary processor2006 implement a redundant safety check. The safety processor 2004 andthe primary processor 2006 provide periodic signals indicating normaloperation. For example, during operation, the safety processor 2004 mayindicate to the primary processor 2006 that the safety processor 2004 isexecuting code and operating normally. The primary processor 2006 may,likewise, indicate to the safety processor 2004 that the primaryprocessor 2006 is executing code and operating normally. In someexamples, communication between the safety processor 2004 and theprimary processor 2006 occurs at a predetermined interval. Thepredetermined interval may be constant or may be variable based on thecircuit state and/or operation of the surgical instrument 10.

FIG. 22 illustrates one example of a power assembly 2100 comprising ausage cycle circuit 2102 configured to monitor a usage cycle count ofthe power assembly 2100. The power assembly 2100 may be coupled to asurgical instrument 2110. The usage cycle circuit 2102 comprises aprocessor 2104 and a use indicator 2106. The use indicator 2106 isconfigured to provide a signal to the processor 2104 to indicate a useof the battery back 2100 and/or a surgical instrument 2110 coupled tothe power assembly 2100. A “use” may comprise any suitable action,condition, and/or parameter such as, for example, changing a modularcomponent of a surgical instrument 2110, deploying or firing adisposable component coupled to the surgical instrument 2110, deliveringelectrosurgical energy from the surgical instrument 2110, reconditioningthe surgical instrument 2110 and/or the power assembly 2100, exchangingthe power assembly 2100, recharging the power assembly 2100, and/orexceeding a safety limitation of the surgical instrument 2110 and/or thebattery back 2100.

In some instances, a usage cycle, or use, is defined by one or morepower assembly 2100 parameters. For example, in one instance, a usagecycle comprises using more than 5% of the total energy available fromthe power assembly 2100 when the power assembly 2100 is at a full chargelevel. In another instance, a usage cycle comprises a continuous energydrain from the power assembly 2100 exceeding a predetermined time limit.For example, a usage cycle may correspond to five minutes of continuousand/or total energy draw from the power assembly 2100. In someinstances, the power assembly 2100 comprises a usage cycle circuit 2102having a continuous power draw to maintain one or more components of theusage cycle circuit 2102, such as, for example, the use indicator 2106and/or a counter 2108, in an active state.

The processor 2104 maintains a usage cycle count. The usage cycle countindicates the number of uses detected by the use indicator 2106 for thepower assembly 2100 and/or the surgical instrument 2110. The processor2104 may increment and/or decrement the usage cycle count based on inputfrom the use indicator 2106. The usage cycle count is used to controlone or more operations of the power assembly 2100 and/or the surgicalinstrument 2110. For example, in some instances, a power assembly 2100is disabled when the usage cycle count exceeds a predetermined usagelimit Although the instances discussed herein are discussed with respectto incrementing the usage cycle count above a predetermined usage limit,those skilled in the art will recognize that the usage cycle count maystart at a predetermined amount and may be decremented by the processor2104. In this instance, the processor 2104 initiates and/or prevents oneor more operations of the power assembly 2100 when the usage cycle countfalls below a predetermined usage limit.

The usage cycle count is maintained by a counter 2108. The counter 2108comprises any suitable circuit, such as, for example, a memory module,an analog counter, and/or any circuit configured to maintain a usagecycle count. In some instances, the counter 2108 is formed integrallywith the processor 2104. In other instances, the counter 2108 comprisesa separate component, such as, for example, a solid state memory module.In some instances, the usage cycle count is provided to a remote system,such as, for example, a central database. The usage cycle count istransmitted by a communications module 2112 to the remote system. Thecommunications module 2112 is configured to use any suitablecommunications medium, such as, for example, wired and/or wirelesscommunication. In some instances, the communications module 2112 isconfigured to receive one or more instructions from the remote system,such as, for example, a control signal when the usage cycle countexceeds the predetermined usage limit.

In some instances, the use indicator 2106 is configured to monitor thenumber of modular components used with a surgical instrument 2110coupled to the power assembly 2100. A modular component may comprise,for example, a modular shaft, a modular end effector, and/or any othermodular component. In some instances, the use indicator 2106 monitorsthe use of one or more disposable components, such as, for example,insertion and/or deployment of a staple cartridge within an end effectorcoupled to the surgical instrument 2110. The use indicator 2106comprises one or more sensors for detecting the exchange of one or moremodular and/or disposable components of the surgical instrument 2110.

In some instances, the use indicator 2106 is configured to monitorsingle patient surgical procedures performed while the power assembly2100 is installed. For example, the use indicator 2106 may be configuredto monitor firings of the surgical instrument 2110 while the powerassembly 2100 is coupled to the surgical instrument 2110. A firing maycorrespond to deployment of a staple cartridge, application ofelectrosurgical energy, and/or any other suitable surgical event. Theuse indicator 2106 may comprise one or more circuits for measuring thenumber of firings while the power assembly 2100 is installed. The useindicator 2106 provides a signal to the processor 2104 when a singlepatient procedure is performed and the processor 2104 increments theusage cycle count.

In some instances, the use indicator 2106 comprises a circuit configuredto monitor one or more parameters of the power source 2114, such as, forexample, a current draw from the power source 2114. The one or moreparameters of the power source 2114 correspond to one or more operationsperformable by the surgical instrument 2110, such as, for example, acutting and sealing operation. The use indicator 2106 provides the oneor more parameters to the processor 2104, which increments the usagecycle count when the one or more parameters indicate that a procedurehas been performed.

In some instances, the use indicator 2106 comprises a timing circuitconfigured to increment a usage cycle count after a predetermined timeperiod. The predetermined time period corresponds to a single patientprocedure time, which is the time required for an operator to perform aprocedure, such as, for example, a cutting and sealing procedure. Whenthe power assembly 2100 is coupled to the surgical instrument 2110, theprocessor 2104 polls the use indicator 2106 to determine when the singlepatient procedure time has expired. When the predetermined time periodhas elapsed, the processor 2104 increments the usage cycle count. Afterincrementing the usage cycle count, the processor 2104 resets the timingcircuit of the use indicator 2106.

In some instances, the use indicator 2106 comprises a time constant thatapproximates the single patient procedure time. In one example, theusage cycle circuit 2102 comprises a resistor-capacitor (RC) timingcircuit 2506. The RC timing circuit comprises a time constant defined bya resistor-capacitor pair. The time constant is defined by the values ofthe resistor and the capacitor. In one example, the usage cycle circuit2552 comprises a rechargeable battery and a clock. When the powerassembly 2100 is installed in a surgical instrument, the rechargeablebattery is charged by the power source. The rechargeable batterycomprises enough power to run the clock for at least the single patientprocedure time. The clock may comprise a real time clock, a processorconfigured to implement a time function, or any other suitable timingcircuit.

Referring still to FIG. 22, in some instances, the use indicator 2106comprises a sensor configured to monitor one or more environmentalconditions experienced by the power assembly 2100. For example, the useindicator 2106 may comprise an accelerometer. The accelerometer isconfigured to monitor acceleration of the power assembly 2100. The powerassembly 2100 comprises a maximum acceleration tolerance. Accelerationabove a predetermined threshold indicates, for example, that the powerassembly 2100 has been dropped. When the use indicator 2106 detectsacceleration above the maximum acceleration tolerance, the processor2104 increments a usage cycle count. In some instances, the useindicator 2106 comprises a moisture sensor. The moisture sensor isconfigured to indicate when the power assembly 2100 has been exposed tomoisture. The moisture sensor may comprise, for example, an immersionsensor configured to indicate when the power assembly 2100 has beenfully immersed in a cleaning fluid, a moisture sensor configured toindicate when moisture is in contact with the power assembly 2100 duringuse, and/or any other suitable moisture sensor.

In some instances, the use indicator 2106 comprises a chemical exposuresensor. The chemical exposure sensor is configured to indicate when thepower assembly 2100 has come into contact with harmful and/or dangerouschemicals. For example, during a sterilization procedure, aninappropriate chemical may be used that leads to degradation of thepower assembly 2100. The processor 2104 increments the usage cycle countwhen the use indicator 2106 detects an inappropriate chemical.

In some instances, the usage cycle circuit 2102 is configured to monitorthe number of reconditioning cycles experienced by the power assembly2100. A reconditioning cycle may comprise, for example, a cleaningcycle, a sterilization cycle, a charging cycle, routine and/orpreventative maintenance, and/or any other suitable reconditioningcycle. The use indicator 2106 is configured to detect a reconditioningcycle. For example, the use indicator 2106 may comprise a moisturesensor to detect a cleaning and/or sterilization cycle. In someinstances, the usage cycle circuit 2102 monitors the number ofreconditioning cycles experienced by the power assembly 2100 anddisables the power assembly 2100 after the number of reconditioningcycles exceeds a predetermined threshold.

The usage cycle circuit 2102 may be configured to monitor the number ofpower assembly 2100 exchanges. The usage cycle circuit 2102 incrementsthe usage cycle count each time the power assembly 2100 is exchanged.When the maximum number of exchanges is exceeded the usage cycle circuit2102 locks out the power assembly 2100 and/or the surgical instrument2110. In some instances, when the power assembly 2100 is coupled thesurgical instrument 2110, the usage cycle circuit 2102 identifies theserial number of the power assembly 2100 and locks the power assembly2100 such that the power assembly 2100 is usable only with the surgicalinstrument 2110. In some instances, the usage cycle circuit 2102increments the usage cycle each time the power assembly 2100 is removedfrom and/or coupled to the surgical instrument 2110.

In some instances, the usage cycle count corresponds to sterilization ofthe power assembly 2100. The use indicator 2106 comprises a sensorconfigured to detect one or more parameters of a sterilization cycle,such as, for example, a temperature parameter, a chemical parameter, amoisture parameter, and/or any other suitable parameter. The processor2104 increments the usage cycle count when a sterilization parameter isdetected. The usage cycle circuit 2102 disables the power assembly 2100after a predetermined number of sterilizations. In some instances, theusage cycle circuit 2102 is reset during a sterilization cycle, avoltage sensor to detect a recharge cycle, and/or any suitable sensor.The processor 2104 increments the usage cycle count when areconditioning cycle is detected. The usage cycle circuit 2102 isdisabled when a sterilization cycle is detected. The usage cycle circuit2102 is reactivated and/or reset when the power assembly 2100 is coupledto the surgical instrument 2110. In some instances, the use indicatorcomprises a zero power indicator. The zero power indicator changes stateduring a sterilization cycle and is checked by the processor 2104 whenthe power assembly 2100 is coupled to a surgical instrument 2110. Whenthe zero power indicator indicates that a sterilization cycle hasoccurred, the processor 2104 increments the usage cycle count.

A counter 2108 maintains the usage cycle count. In some instances, thecounter 2108 comprises a non-volatile memory module. The processor 2104increments the usage cycle count stored in the non-volatile memorymodule each time a usage cycle is detected. The memory module may beaccessed by the processor 2104 and/or a control circuit, such as, forexample, the control circuit 200. When the usage cycle count exceeds apredetermined threshold, the processor 2104 disables the power assembly2100. In some instances, the usage cycle count is maintained by aplurality of circuit components. For example, in one instance, thecounter 2108 comprises a resistor (or fuse) pack. After each use of thepower assembly 2100, a resistor (or fuse) is burned to an open position,changing the resistance of the resistor pack. The power assembly 2100and/or the surgical instrument 2110 reads the remaining resistance. Whenthe last resistor of the resistor pack is burned out, the resistor packhas a predetermined resistance, such as, for example, an infiniteresistance corresponding to an open circuit, which indicates that thepower assembly 2100 has reached its usage limit. In some instances, theresistance of the resistor pack is used to derive the number of usesremaining.

In some instances, the usage cycle circuit 2102 prevents further use ofthe power assembly 2100 and/or the surgical instrument 2110 when theusage cycle count exceeds a predetermined usage limit. In one instance,the usage cycle count associated with the power assembly 2100 isprovided to an operator, for example, utilizing a screen formedintegrally with the surgical instrument 2110. The surgical instrument2110 provides an indication to the operator that the usage cycle counthas exceeded a predetermined limit for the power assembly 2100, andprevents further operation of the surgical instrument 2110.

In some instances, the usage cycle circuit 2102 is configured tophysically prevent operation when the predetermined usage limit isreached. For example, the power assembly 2100 may comprise a shieldconfigured to deploy over contacts of the power assembly 2100 when theusage cycle count exceeds the predetermined usage limit. The shieldprevents recharge and use of the power assembly 2100 by covering theelectrical connections of the power assembly 2100.

In some instances, the usage cycle circuit 2102 is located at leastpartially within the surgical instrument 2110 and is configured tomaintain a usage cycle count for the surgical instrument 2110. FIG. 22illustrates one or more components of the usage cycle circuit 2102within the surgical instrument 2110 in phantom, illustrating thealternative positioning of the usage cycle circuit 2102. When apredetermined usage limit of the surgical instrument 2110 is exceeded,the usage cycle circuit 2102 disables and/or prevents operation of thesurgical instrument 2110. The usage cycle count is incremented by theusage cycle circuit 2102 when the use indicator 2106 detects a specificevent and/or requirement, such as, for example, firing of the surgicalinstrument 2110, a predetermined time period corresponding to a singlepatient procedure time, based on one or more motor parameters of thesurgical instrument 2110, in response to a system diagnostic indicatingthat one or more predetermined thresholds are met, and/or any othersuitable requirement. As discussed above, in some instances, the useindicator 2106 comprises a timing circuit corresponding to a singlepatient procedure time. In other instances, the use indicator 2106comprises one or more sensors configured to detect a specific eventand/or condition of the surgical instrument 2110.

In some instances, the usage cycle circuit 2102 is configured to preventoperation of the surgical instrument 2110 after the predetermined usagelimit is reached. In some instances, the surgical instrument 2110comprises a visible indicator to indicate when the predetermined usagelimit has been reached and/or exceeded. For example, a flag, such as ared flag, may pop-up from the surgical instrument 2110, such as from thehandle, to provide a visual indication to the operator that the surgicalinstrument 2110 has exceeded the predetermined usage limit. As anotherexample, the usage cycle circuit 2102 may be coupled to a display formedintegrally with the surgical instrument 2110. The usage cycle circuit2102 displays a message indicating that the predetermined usage limithas been exceeded. The surgical instrument 2110 may provide an audibleindication to the operator that the predetermined usage limit has beenexceeded. For example, in one instance, the surgical instrument 2110emits an audible tone when the predetermined usage limit is exceeded andthe power assembly 2100 is removed from the surgical instrument 2110.The audible tone indicates the last use of the surgical instrument 2110and indicates that the surgical instrument 2110 should be disposed orreconditioned.

In some instances, the usage cycle circuit 2102 is configured totransmit the usage cycle count of the surgical instrument 2110 to aremote location, such as, for example, a central database. The usagecycle circuit 2102 comprises a communications module 2112 configured totransmit the usage cycle count to the remote location. Thecommunications module 2112 may utilize any suitable communicationssystem, such as, for example, wired or wireless communications system.The remote location may comprise a central database configured tomaintain usage information. In some instances, when the power assembly2100 is coupled to the surgical instrument 2110, the power assembly 2100records a serial number of the surgical instrument 2110. The serialnumber is transmitted to the central database, for example, when thepower assembly 2100 is coupled to a charger. In some instances, thecentral database maintains a count corresponding to each use of thesurgical instrument 2110. For example, a bar code associated with thesurgical instrument 2110 may be scanned each time the surgicalinstrument 2110 is used. When the use count exceeds a predeterminedusage limit, the central database provides a signal to the surgicalinstrument 2110 indicating that the surgical instrument 2110 should bediscarded.

The surgical instrument 2110 may be configured to lock and/or preventoperation of the surgical instrument 2110 when the usage cycle countexceeds a predetermined usage limit. In some instances, the surgicalinstrument 2110 comprises a disposable instrument and is discarded afterthe usage cycle count exceeds the predetermined usage limit. In otherinstances, the surgical instrument 2110 comprises a reusable surgicalinstrument which may be reconditioned after the usage cycle countexceeds the predetermined usage limit. The surgical instrument 2110initiates a reversible lockout after the predetermined usage limit ismet. A technician reconditions the surgical instrument 2110 and releasesthe lockout, for example, utilizing a specialized technician keyconfigured to reset the usage cycle circuit 2102.

In some aspects, the segmented circuit 2000 is configured for sequentialstart-up. An error check is performed by each circuit segment 2002a-2002 g prior to energizing the next sequential circuit segment 2002a-2002 g. FIG. 23 illustrates one example of a process for sequentiallyenergizing a segmented circuit 2270, such as, for example, the segmentedcircuit 2000. When a battery 2008 is coupled to the segmented circuit2000, the safety processor 2004 is energized 2272. The safety processor2004 performs a self-error check 2274. When an error is detected 2276 a,the safety processor stops energizing the segmented circuit 2000 andgenerates an error code 2278 a. When no errors are detected 2276 b, thesafety processor 2004 initiates 2278 b power-up of the primary processor2006. The primary processor 2006 performs a self-error check. When noerrors are detected, the primary processor 2006 begins sequentialpower-up of each of the remaining circuit segments 2278 b. Each circuitsegment is energized and error checked by the primary processor 2006.When no errors are detected, the next circuit segment is energized 2278b. When an error is detected, the safety processor 2004 and/or theprimary process stops energizing the current segment and generates anerror 2278 a. The sequential start-up continues until all of the circuitsegments 2002 a-2002 g have been energized. In some examples, thesegmented circuit 2000 transitions from sleep mode following a similarsequential power-up process 11250.

FIG. 24 illustrates one aspect of a power segment 2302 comprising aplurality of daisy chained power converters 2314, 2316, 2318. The powersegment 2302 comprises a battery 2308. The battery 2308 is configured toprovide a source voltage, such as, for example, 12V. A current sensor2312 is coupled to the battery 2308 to monitor the current draw of asegmented circuit and/or one or more circuit segments. The currentsensor 2312 is coupled to an FET switch 2313. The battery 2308 iscoupled to one or more voltage converters 2309, 2314, 2316. An always onconverter 2309 provides a constant voltage to one or more circuitcomponents, such as, for example, a motion sensor 2322. The always onconverter 2309 comprises, for example, a 3.3V converter. The always onconverter 2309 may provide a constant voltage to additional circuitcomponents, such as, for example, a safety processor (not shown). Thebattery 2308 is coupled to a boost converter 2318. The boost converter2318 is configured to provide a boosted voltage above the voltageprovided by the battery 2308. For example, in the illustrated example,the battery 2308 provides a voltage of 12V. The boost converter 2318 isconfigured to boost the voltage to 13V. The boost converter 2318 isconfigured to maintain a minimum voltage during operation of a surgicalinstrument, for example, the surgical instrument 10 (FIGS. 1-4).Operation of a motor can result in the power provided to the primaryprocessor 2306 dropping below a minimum threshold and creating abrownout or reset condition in the primary processor 2306. The boostconverter 2318 ensures that sufficient power is available to the primaryprocessor 2306 and/or other circuit components, such as the motorcontroller 2343, during operation of the surgical instrument 10. In someexamples, the boost converter 2318 is coupled directly one or morecircuit components, such as, for example, an OLED display 2388.

The boost converter 2318 is coupled to one or more step-down convertersto provide voltages below the boosted voltage level. A first voltageconverter 2316 is coupled to the boost converter 2318 and provides afirst stepped-down voltage to one or more circuit components. In theillustrated example, the first voltage converter 2316 provides a voltageof 5V. The first voltage converter 2316 is coupled to a rotary positionencoder 2340. A FET switch 2317 is coupled between the first voltageconverter 2316 and the rotary position encoder 2340. The FET switch 2317is controlled by the processor 2306. The processor 2306 opens the FETswitch 2317 to deactivate the position encoder 2340, for example, duringpower intensive operations. The first voltage converter 2316 is coupledto a second voltage converter 2314 configured to provide a secondstepped-down voltage. The second stepped-down voltage comprises, forexample, 3.3V. The second voltage converter 2314 is coupled to aprocessor 2306. In some examples, the boost converter 2318, the firstvoltage converter 2316, and the second voltage converter 2314 arecoupled in a daisy chain configuration. The daisy chain configurationallows the use of smaller, more efficient converters for generatingvoltage levels below the boosted voltage level. The examples, however,are not limited to the particular voltage range(s) described in thecontext of this specification.

FIG. 25 illustrates one aspect of a segmented circuit 2400 configured tomaximize power available for critical and/or power intense functions.The segmented circuit 2400 comprises a battery 2408. The battery 2408 isconfigured to provide a source voltage such as, for example, 12V. Thesource voltage is provided to a plurality of voltage converters 2409,2418. An always-on voltage converter 2409 provides a constant voltage toone or more circuit components, for example, a motion sensor 2422 and asafety processor 2404. The always-on voltage converter 2409 is directlycoupled to the battery 2408. The always-on converter 2409 provides avoltage of 3.3V, for example. The examples, however, are not limited tothe particular voltage range(s) described in the context of thisspecification.

The segmented circuit 2400 comprises a boost converter 2418. The boostconverter 2418 provides a boosted voltage above the source voltageprovided by the battery 2408, such as, for example, 13V. The boostconverter 2418 provides a boosted voltage directly to one or morecircuit components, such as, for example, an OLED display 2488 and amotor controller 2443. By coupling the OLED display 2488 directly to theboost converter 2418, the segmented circuit 2400 eliminates the need fora power converter dedicated to the OLED display 2488. The boostconverter 2418 provides a boosted voltage to the motor controller 2443and the motor 2448 during one or more power intensive operations of themotor 2448, such as, for example, a cutting operation. The boostconverter 2418 is coupled to a step-down converter 2416. The step-downconverter 2416 is configured to provide a voltage below the boostedvoltage to one or more circuit components, such as, for example, 5V. Thestep-down converter 2416 is coupled to, for example, a FET switch 2451and a position encoder 2440. The FET switch 2451 is coupled to theprimary processor 2406. The primary processor 2406 opens the FET switch2451 when transitioning the segmented circuit 2400 to sleep mode and/orduring power intensive functions requiring additional voltage deliveredto the motor 2448. Opening the FET switch 2451 deactivates the positionencoder 2440 and eliminates the power draw of the position encoder 2440.The examples, however, are not limited to the particular voltagerange(s) described in the context of this specification.

The step-down converter 2416 is coupled to a linear converter 2414. Thelinear converter 2414 is configured to provide a voltage of, forexample, 3.3V. The linear converter 2414 is coupled to the primaryprocessor 2406. The linear converter 2414 provides an operating voltageto the primary processor 2406. The linear converter 2414 may be coupledto one or more additional circuit components. The examples, however, arenot limited to the particular voltage range(s) described in the contextof this specification.

The segmented circuit 2400 comprises a bailout switch 2456. The bailoutswitch 2456 is coupled to a bailout door on the surgical instrument 10.The bailout switch 2456 and the safety processor 2404 are coupled to anAND gate 2419. The AND gate 2419 provides an input to a FET switch 2413.When the bailout switch 2456 detects a bailout condition, the bailoutswitch 2456 provides a bailout shutdown signal to the AND gate 2419.When the safety processor 2404 detects an unsafe condition, such as, forexample, due to a sensor mismatch, the safety processor 2404 provides ashutdown signal to the AND gate 2419. In some examples, both the bailoutshutdown signal and the shutdown signal are high during normal operationand are low when a bailout condition or an unsafe condition is detected.When the output of the AND gate 2419 is low, the FET switch 2413 isopened and operation of the motor 2448 is prevented. In some examples,the safety processor 2404 utilizes the shutdown signal to transition themotor 2448 to an off state in sleep mode. A third input to the FETswitch 2413 is provided by a current sensor 2412 coupled to the battery2408. The current sensor 2412 monitors the current drawn by the circuit2400 and opens the FET switch 2413 to shut-off power to the motor 2448when an electrical current above a predetermined threshold is detected.The FET switch 2413 and the motor controller 2443 are coupled to a bankof FET switches 2445 configured to control operation of the motor 2448.

A motor current sensor 2446 is coupled in series with the motor 2448 toprovide a motor current sensor reading to a current monitor 2447. Thecurrent monitor 2447 is coupled to the primary processor 2406. Thecurrent monitor 2447 provides a signal indicative of the current draw ofthe motor 2448. The primary processor 2406 may utilize the signal fromthe motor current 2447 to control operation of the motor, for example,to ensure the current draw of the motor 2448 is within an acceptablerange, to compare the current draw of the motor 2448 to one or moreother parameters of the circuit 2400 such as, for example, the positionencoder 2440, and/or to determine one or more parameters of a treatmentsite. In some examples, the current monitor 2447 may be coupled to thesafety processor 2404.

In some aspects, actuation of one or more handle controls, such as, forexample, a firing trigger, causes the primary processor 2406 to decreasepower to one or more components while the handle control is actuated.For example, in one example, a firing trigger controls a firing strokeof a cutting member. The cutting member is driven by the motor 2448.Actuation of the firing trigger results in forward operation of themotor 2448 and advancement of the cutting member. During firing, theprimary processor 2406 closes the FET switch 2451 to remove power fromthe position encoder 2440. The deactivation of one or more circuitcomponents allows higher power to be delivered to the motor 2448. Whenthe firing trigger is released, full power is restored to thedeactivated components, for example, by closing the FET switch 2451 andreactivating the position encoder 2440.

In some aspects, the safety processor 2404 controls operation of thesegmented circuit 2400. For example, the safety processor 2404 mayinitiate a sequential power-up of the segmented circuit 2400, transitionof the segmented circuit 2400 to and from sleep mode, and/or mayoverride one or more control signals from the primary processor 2406.For example, in the illustrated example, the safety processor 2404 iscoupled to the step-down converter 2416. The safety processor 2404controls operation of the segmented circuit 2400 by activating ordeactivating the step-down converter 2416 to provide power to theremainder of the segmented circuit 2400.

FIG. 26 illustrates one aspect of a power system 2500 comprising aplurality of daisy chained power converters 2514, 2516, 2518 configuredto be sequentially energized. The plurality of daisy chained powerconverters 2514, 2516, 2518 may be sequentially activated by, forexample, a safety processor during initial power-up and/or transitionfrom sleep mode. The safety processor may be powered by an independentpower converter (not shown). For example, in one example, when a batteryvoltage V_(BATT) is coupled to the power system 2500 and/or anaccelerometer detects movement in sleep mode, the safety processorinitiates a sequential start-up of the daisy chained power converters2514, 2516, 2518. The safety processor activates the 13V boost section2518. The boost section 2518 is energized and performs a self-check. Insome examples, the boost section 2518 comprises an integrated circuit2520 configured to boost the source voltage and to perform a self check.A diode D prevents power-up of a 5V supply section 2516 until the boostsection 2518 has completed a self-check and provided a signal to thediode D indicating that the boost section 2518 did not identify anyerrors. In some examples, this signal is provided by the safetyprocessor. The examples, however, are not limited to the particularvoltage range(s) described in the context of this specification.

The 5V supply section 2516 is sequentially powered-up after the boostsection 2518. The 5V supply section 2516 performs a self-check duringpower-up to identify any errors in the 5V supply section 2516. The 5Vsupply section 2516 comprises an integrated circuit 2515 configured toprovide a step-down voltage from the boost voltage and to perform anerror check. When no errors are detected, the 5V supply section 2516completes sequential power-up and provides an activation signal to the3.3V supply section 2514. In some examples, the safety processorprovides an activation signal to the 3.3V supply section 2514. The 3.3Vsupply section comprises an integrated circuit 2513 configured toprovide a step-down voltage from the 5V supply section 2516 and performa self-error check during power-up. When no errors are detected duringthe self-check, the 3.3V supply section 2514 provides power to theprimary processor. The primary processor is configured to sequentiallyenergize each of the remaining circuit segments. By sequentiallyenergizing the power system 2500 and/or the remainder of a segmentedcircuit, the power system 2500 reduces error risks, allows forstabilization of voltage levels before loads are applied, and preventslarge current draws from all hardware being turned on simultaneously inan uncontrolled manner. The examples, however, are not limited to theparticular voltage range(s) described in the context of thisspecification.

In one aspect, the power system 2500 comprises an over voltageidentification and mitigation circuit. The over voltage identificationand mitigation circuit is configured to detect a monopolar returncurrent in the surgical instrument and interrupt power from the powersegment when the monopolar return current is detected. The over voltageidentification and mitigation circuit is configured to identify groundfloatation of the power system. The over voltage identification andmitigation circuit comprises a metal oxide varistor. The over voltageidentification and mitigation circuit comprises at least one transientvoltage suppression diode.

FIG. 27 illustrates one aspect of a segmented circuit 2600 comprising anisolated control section 2602. The isolated control section 2602isolates control hardware of the segmented circuit 2600 from a powersection (not shown) of the segmented circuit 2600. The control section2602 comprises, for example, a primary processor 2606, a safetyprocessor (not shown), and/or additional control hardware, for example,a FET Switch 2617. The power section comprises, for example, a motor, amotor driver, and/or a plurality of motor MOSFETS. The isolated controlsection 2602 comprises a charging circuit 2603 and a rechargeablebattery 2608 coupled to a 5V power converter 2616. The charging circuit2603 and the rechargeable battery 2608 isolate the primary processor2606 from the power section. In some examples, the rechargeable battery2608 is coupled to a safety processor and any additional supporthardware. Isolating the control section 2602 from the power sectionallows the control section 2602, for example, the primary processor2606, to remain active even when main power is removed, provides afilter, through the rechargeable battery 2608, to keep noise out of thecontrol section 2602, isolates the control section 2602 from heavyswings in the battery voltage to ensure proper operation even duringheavy motor loads, and/or allows for real-time operating system (RTOS)to be used by the segmented circuit 2600. In some examples, therechargeable battery 2608 provides a stepped-down voltage to the primaryprocessor, such as, for example, 3.3V. The examples, however, are notlimited to the particular voltage range(s) described in the context ofthis specification.

FIGS. 28A and 28B illustrate another aspect of a control circuit 3000configured to control the powered surgical instrument 10, illustrated inFIGS. 1-18A. As shown in FIGS. 18A, 28B, the handle assembly 14 mayinclude a motor 3014 which can be controlled by a motor driver 3015 andcan be employed by the firing system of the surgical instrument 10. Invarious forms, the motor 3014 may be a DC brushed driving motor having amaximum rotation of, approximately, 25,000 RPM, for example. In otherarrangements, the motor 3014 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. In certain circumstances, the motor driver 3015 maycomprise an H-Bridge FETs 3019, as illustrated in FIGS. 28A and 28B, forexample. The motor 3014 can be powered by a power assembly 3006, whichcan be releasably mounted to the handle assembly 14. The power assembly3006 is configured to supply control power to the surgical instrument10. The power assembly 3006 may comprise a battery which may include anumber of battery cells connected in series that can be used as thepower source to power the surgical instrument 10. In such configuration,the power assembly 3006 may be referred to as a battery pack. In certaincircumstances, the battery cells of the power assembly 3006 may bereplaceable and/or rechargeable. In at least one example, the batterycells can be Lithium-Ion batteries which can be separably couplable tothe power assembly 3006.

Examples of drive systems and closure systems that are suitable for usewith the surgical instrument 10 are disclosed in U.S. Provisional PatentApplication Ser. No. 61/782,866, entitled CONTROL SYSTEM OF A SURGICALINSTRUMENT, and filed Mar. 14, 2013, the entire disclosure of which isincorporated by reference herein in its entirety. For example, theelectric motor 3014 can include a rotatable shaft (not shown) that mayoperably interface with a gear reducer assembly that can be mounted inmeshing engagement with a set, or rack, of drive teeth on alongitudinally-movable drive member. In use, a voltage polarity providedby the battery can operate the electric motor 3014 to drive thelongitudinally-movable drive member to effectuate the end effector 300.For example, the motor 3014 can be configured to drive thelongitudinally-movable drive member to advance a firing mechanism tofire staples into tissue captured by the end effector 300 from a staplecartridge assembled with the end effector 300 and/or advance a cuttingmember to cut tissue captured by the end effector 300, for example.

As illustrated in FIGS. 28A and 28B and as described below in greaterdetail, the power assembly 3006 may include a power managementcontroller which can be configured to modulate the power output of thepower assembly 3006 to deliver a first power output to power the motor3014 to advance the cutting member while the interchangeable shaft 200is coupled to the handle assembly 14 (FIG. 1) and to deliver a secondpower output to power the motor 3014 to advance the cutting member whilethe interchangeable shaft assembly 200 is coupled to the handle assembly14, for example. Such modulation can be beneficial in avoidingtransmission of excessive power to the motor 3014 beyond therequirements of an interchangeable shaft assembly that is coupled to thehandle assembly 14.

In certain circumstances, the interface 3024 can facilitate transmissionof the one or more communication signals between the power managementcontroller 3016 and the shaft assembly controller 3022 by routing suchcommunication signals through a main controller 3017 residing in thehandle assembly 14 (FIG. 1), for example. In other circumstances, theinterface 3024 can facilitate a direct line of communication between thepower management controller 3016 and the shaft assembly controller 3022through the handle assembly 14 while the shaft assembly 200 (FIG. 1) andthe power assembly 3006 are coupled to the handle assembly 14.

In one instance, the main microcontroller 3017 may be any single core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one instance, the surgical instrument 10 (FIGS.1-4) may comprise a power management controller 3016 such as, forexample, a safety microcontroller platform comprising twomicrocontroller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments.Nevertheless, other suitable substitutes for microcontrollers and safetyprocessor may be employed, without limitation. In one instance, thesafety processor 2004 (FIG. 21A) may be configured specifically for IEC61508 and ISO 26262 safety critical applications, among others, toprovide advanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

In certain instances, the microcontroller 3017 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QEI) analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available for the productdatasheet. The present disclosure should not be limited in this context.

FIG. 29 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly 14 (FIG. 1) and thepower assembly and between the handle assembly 14 and theinterchangeable shaft assembly. As shown in FIG. 29, the power assembly3006 may include a power management circuit 3034 which may comprise thepower management controller 3016, a power modulator 3038, and a currentsense circuit 3036. The power management circuit 3034 can be configuredto modulate power output of the battery 3007 based on the powerrequirements of the shaft assembly 200 (FIG. 1) while the shaft assembly200 and the power assembly 3006 are coupled to the handle assembly 14.For example, the power management controller 3016 can be programmed tocontrol the power modulator 3038 of the power output of the powerassembly 3006 and the current sense circuit 3036 can be employed tomonitor power output of the power assembly 3006 to provide feedback tothe power management controller 3016 about the power output of thebattery 3007 so that the power management controller 3016 may adjust thepower output of the power assembly 3006 to maintain a desired output.

It is noteworthy that the power management controller 3016 and/or theshaft assembly controller 3022 each may comprise one or more processorsand/or memory units which may store a number of software modules.Although certain modules and/or blocks of the surgical instrument 14(FIG. 1) may be described by way of example, it can be appreciated thata greater or lesser number of modules and/or blocks may be used.Further, although various instances may be described in terms of modulesand/or blocks to facilitate description, such modules and/or blocks maybe implemented by one or more hardware components, e.g., processors,Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs),Application Specific Integrated Circuits (ASICs), circuits, registersand/or software components, e.g., programs, subroutines, logic and/orcombinations of hardware and software components.

In certain instances, the surgical instrument 10 (FIGS. 1-4) maycomprise an output device 3042 which may include one or more devices forproviding a sensory feedback to a user. Such devices may comprise, forexample, visual feedback devices (e.g., an LCD display screen, LEDindicators), audio feedback devices (e.g., a speaker, a buzzer) ortactile feedback devices (e.g., haptic actuators). In certaincircumstances, the output device 3042 may comprise a display 3043 whichmay be included in the handle assembly 14 (FIG. 1). The shaft assemblycontroller 3022 and/or the power management controller 3016 can providefeedback to a user of the surgical instrument 10 through the outputdevice 3042. The interface 3024 can be configured to connect the shaftassembly controller 3022 and/or the power management controller 3016 tothe output device 3042. The reader will appreciate that the outputdevice 3042 can instead be integrated with the power assembly 3006. Insuch circumstances, communication between the output device 3042 and theshaft assembly controller 3022 may be accomplished through the interface3024 while the shaft assembly 200 is coupled to the handle assembly 14.

Having described a surgical instrument 10 (FIGS. 1-4) and variouscontrol circuits 2000, 3000 for controlling the operation thereof, thedisclosure now turns to various specific configurations of the surgicalinstrument 10 and control circuits 2000 (or 3000).

In various aspects the present disclosure provides techniques for datastorage and usage. In one aspect, data storage and usage is based onmultiple levels of action thresholds. Such thresholds include upper andlower ultimate threshold limits, ultimate threshold that shuts downmotor or activates return is current, pressure, firing load, torque isexceeded, and alternatively, while running within the limits the deviceautomatically compensates for loading of the motor.

In one aspect, the instrument 10 (described in connection with FIGS.1-29) can be configured to monitor upper and lower ultimate thresholdlimits to maintain minimum and maximum closure clamp loads withinacceptable limits. If a minimum is not achieved the instrument 10 cannotstart or if it drops below minimum a user action is required. If theclamp load is at a suitable level but drops under minimum during firing,the instrument 10 can adjust the speed of the motor or warn the user. Ifthe minimum limit is breached during operation the unit could give awarning that the firing may not be completely as anticipated. Theinstrument 10 also can be configured to monitor when the battery voltagedrops below the lower ultimate limit the remaining battery power is onlydirect able towards returning the device to the I-beam parked state. Theopening force on the anvil can be employed to sense jams in the endeffector. Alternatively, the instrument 10 can be configured to monitorwhen the motor current goes up or the related speed goes down, then themotor control increases pulse width or frequency modulation to keepspeed constant.

In another aspect, the instrument 10 can (FIG. 1) be configured todetect an ultimate threshold of current draw, pressure, firing load,torque such that when any of these thresholds are exceeded, theinstrument 10 shuts down the motor or causes the motor to return theknife to a pre-fired position. A secondary threshold, which is less thanthe ultimate threshold, may be employed to alter the motor controlprogram to accommodate changes in conditions by changing the motorcontrol parameters. A marginal threshold can be configured as a stepfunction or a ramp function based on a proportionate response to anothercounter or input. For example, in the case of sterilization, no changesbetween 0-200 sterilization cycles, slow motor 1% per use from 201-400sterilization cycles, and prevent use over 400 sterilization cycles. Thespeed of the motor also can be varied based on tissue gap and currentdraw.

There are many parameters that could influence the ideal function of apowered reusable stapler device. Most of these parameters have anultimate maximum and/or minimum threshold beyond which the device shouldnot be operated. Nevertheless, there are also marginal limits that mayinfluence the functional operation of the device. These multiple limits,from multiple parameters may provide an overlying and cumulative effecton the operations program of the device.

Accordingly, the present disclosure relates to surgical instruments and,in various circumstances, to surgical stapling and cutting instrumentsand staple cartridges therefor that are designed to staple and cuttissue.

Efficient performance of an electromechanical device depends on variousfactors. One is the operational envelope, i.e., range of parameters,conditions and events in which the device carries out its intendedfunctions. For example, for a device powered by a motor driven byelectrical current, there may be an operational region above a certainelectrical current threshold where the device runs more inefficientlythan desired. Put another way, there may be an upper “speed limit” abovewhich there is decreasing efficiency. Such an upper threshold may havevalue in preventing substantial inefficiencies or even devicedegradation.

There may be thresholds within an operational envelope, however, thatmay form regions exploitable to enhance efficiency within operationalstates. In other words, there may be regions where the device can adjustand perform better within a defined operational envelope (orsub-envelope). Such a region can be one between a marginal threshold andan ultimate threshold. In addition, these regions may comprise “sweetspots” or a predetermined optional range or point. These regions alsomay comprise a large range within which performance is judged to beadequate.

An ultimate threshold can be defined, above which or below which anaction or actions could be taken (or refrained from being taken) such asstopping the device. In addition, a marginal threshold or thresholds canbe defined, above which or below which an action or actions could betaken (or refrained from being taken). By way of non-limiting example, amarginal threshold can be set to define where the current draw of themotor exceeds 75% of an ultimate threshold. Exceeding the marginalthreshold can result, for example, in the device's beginning to slowmotor speed at an increasing rate as it continues to climb toward theultimate threshold.

Various mechanisms can be employed to carry out the adjustment(s) takenas a result of exceeding a threshold. For example, the adjustment canreflect a step function. It can also reflect a ramped function. Otherfunctions can be utilized.

In various aspects, to enhance performance by additional mechanisms, anoverlaying threshold can be defined. An overlaying threshold cancomprise one or more thresholds defined by multiple parameters. Anoverlaying threshold can result in one or more thresholds being an inputinto the generation of another threshold or thresholds. An overlayingthreshold can be predetermined or dynamically generated such as atruntime. The overlaying threshold may come into effect when you thethreshold is defined by multiple inputs. For example, as the number ofsterilization cycles exceeds 300 (the marginal threshold) but not 500(the ultimate threshold) the device runs the motor slower. Then as thecurrent draw exceeds its 75% marginal threshold it multiples the slowdown going even slower.

FIG. 30 is a logic diagram disclosing aspects of a multiple-levelthreshold system wherein a threshold rules framework 4000. Parameterscan be identified 4010, such parameters representing quantities,amounts, states, events or more. For example, parameters identified caninclude one or more of current, voltage, tissue pressure, tissuethickness, jaw closure rate, tissue creep rate, firing load, knifethickness, torque, or battery usage. An ultimate threshold or thresholdsfor these parameters can be identified 4012. For instance, apredetermined current draw can be identified. As but one example, anultimate electrical current draw threshold may be defined as 100% of aselected current magnitude. There can be an upper ultimate threshold, alower ultimate threshold, multiple lower or upper ultimate thresholdsdepending on the circumstances, or a range defining an ultimatethreshold. It will be appreciated that an “ultimate” threshold can bedefined and/or calibrated in such a way as to remain essentially aunitary threshold but embody various action triggers. A marginalthreshold or thresholds can be identified 4014. If the marginalthreshold is exceeded, a motor control program can alter operations toaccommodate change.

One or more thresholds can be monitored an acted on during a singlesurgical procedure, wherein the thresholds are independent of each otherwith no interaction. In addition, there can be an interactiveassociation between thresholds of two or more parameters. For example, amarginal threshold for a parameter based on current draw can be 75% ofthe ultimate threshold. In addition, in connection with a parameterbased on number of sterilization cycles, a marginal threshold may be setat 200 sterilization cycles, and an ultimate threshold at sterilization400 cycles. Motor use can proceed normally from 0-199 cycles, and thenslow by 1% from 200 cycles to 399. At cycle 400, motor use can beprevented. It will be appreciated, however, that there can be aninteractive effect. In other words, because motor speed is reduced by 1%due to exceeding the sterilization cycle threshold, the current drawthreshold can be correspondingly adjusted. This interactive effect canresult in the motor running more slowly than it would if either inputwere considered independently.

Thus, the value of one threshold can be an input into the value ofanother threshold, or one threshold can be completely independent ofanother threshold. Where two or more thresholds are activated, it can beconsidered that there can be an overlaying threshold. As a result,multiple thresholds, defining multiple boundaries and limits, can havean overlaying or cumulative effect on operations of instrument 10 (FIGS.1-4). And, one threshold in a multiple-threshold operation scenario canhave a cause-and-effect with another threshold, or there may be nocause-and-effect and the thresholds may exist independent of each other.

In addition, a threshold can be dynamically set and/or reset dependingon conditions experienced during surgery or other conditions. In otherwords, prior to a given surgical procedure, a module or modules can bepreprogrammed into instrument 10 (FIGS. 1-4) or uploaded as needed.Also, a threshold can be dynamically determined, or uploaded, during asurgical procedure.

Turning briefly now to FIG. 1, numerous parameters can be assignedthresholds. Thus, in examples thresholds may be assigned based on tissuegap between the anvil 306 and staple cartridge 304, or anvil 306 andsecond jaw member 302, of an end effector 300, and motor speed variedthereby. In addition, in example thresholds based on current can varymotor speed control. Further, in various examples ultimate, marginal andoverlaying thresholds can be established in connection with closureclamp loads in furtherance of an acceptable operating range. Plus, invarious examples opening force on an anvil 306 can help to detect a jam.Further, in various examples if a minimum threshold is not achieved, thesystem may be prevented from starting or if it drops below a minimumthen a user action can be required.

Still with reference to FIG. 1, in various aspects, it can be determinedwhether clamp load is acceptable and when clamp load drops under aminimum threshold during firing the speed of the motor can be adjustedand/or the clinician warned. In various examples, when a minimumthreshold is exceeded during operation, instrument 10 can give a warningthat the firing may not be completely as anticipated. Moreover, invarious examples thresholds can be assigned wherein if battery chargefalls below a threshold then remaining battery charge can be used toreturn the device to a parked state with respect to the I-beam.

However, thresholds can be referenced even during operations that do notexceed a threshold. Thus, for example, instrument 10 can, while running“within limits”, compensate for the loading of the motor. For instance,if current goes up or related speed goes down, then motor control canincrease pulse width or frequency modulation to help to maintain aconstant speed. In other words, measures can be taken to improve and/oroptimize operations of instrument 10 even while running “within limits.”

In addition, dynamically during a surgical procedure, a threshold can bemodified, or a new threshold generated. This can occur after severalevents including adjusting operations of the instrument 10.

Turning now back to FIG. 30, in various aspects a parameter orparameters are identified 4010. Further, an ultimate threshold orthresholds for a given parameter(s) are identified 4012. In addition, amarginal threshold or thresholds for a given parameter(s) are identified4014. Measures 4010, 4012, and 4014 can be accomplished prior to theprocedure, during the procedure, or both.

Measurements of a parameter(s) are obtained 4016. It can be determinedwhether the measurement of a given parameter exceeds an upper or lowerultimate threshold for the parameter 4018. When the answer is no, it canbe determined whether the measurement of a given parameter exceeds anupper or lower marginal threshold for the parameter 4020. When theanswer is no, operations can be continued 4026. And, measurements of agiven parameter(s) can be again obtained.

When, however, the answer is yes to whether the measurement of a givenparameter exceeds an upper or lower ultimate threshold for the parameter4018, control can pass to where operations can be adjusted 4022. Manytypes of adjustments can be made. One example is to vary motor speed. Itcan be determined whether to modify a given threshold and/or generate anew threshold 4024. This can occur after operations have been adjusted4022.

After operations are adjusted, it can be determined whether to modify athreshold or generate a new threshold. For example, a marginal thresholdinitially set at 75% can be set to a different value. In addition, a newthreshold on the same parameter, or a new threshold on a new parameter,can be generated if desired.

Upon determining whether to modify a threshold or generate a new one,control can pass back to step 4016 where measurement of a parameter(s)is obtained. In addition, control can proceed to identify 4010parameters.

When the answer to whether the measurement exceeds an upper or lowerultimate threshold is no, however, then it can be determined when themeasurement exceeds an upper or lower marginal threshold. When theanswer is yes, then operations can be adjusted 4022 and control proceedas above. When the answer is no, operations can be continued 4026 andcontrol proceed to measuring a parameter(s).

It will be appreciated that the sequence of steps can be varied and isnot limited to that specifically disclosed in FIG. 30. As just oneexample, after obtaining measurement of a parameter(s) 4016, it can thenbe determined whether a marginal threshold is exceeded 4020. Inaddition, an overlaying threshold can expressly be identified andconsidered in the course of the flow.

FIG. 31 is a graphical representation 4100 of instrument systemparameters versus time depicting how, in one aspect, instrument systemparameters can be adjusted in the event that a threshold is reached.Time (t) is shown along a horizontal (x) axis 4102 and the instrumentSystem Parameter is shown along a vertical (y) axis 4104, marginalthreshold 4104 and ultimate threshold 4106. In the graphicalrepresentation 4100 depicted in FIG. 34, the y-axis parameter 4102 isthe one to which a threshold of instrument system parameter is assignedand the x-axis 4102 represents time. At a certain time during operationof instrument 10 (FIGS. 1-4), as evidenced by function 4110, ameasurement can indicate that marginal threshold 4106 is reached. Atthis point, operations of the instrument 10 (FIGS. 1-4) can be adjusted.For example, when the y-axis 4104 parameter is electrical current drawby a motor, a function can be imposed on the subsequent electricalcurrent draw and limit current in some fashion. In one example, thefunction can represent a linear progression 4112. At a certain time inthe course of operation, an ultimate threshold 4108 can be reached. Atthis point, electrical current can be discontinued 4114. Accordingly, anadjustment mechanism can be accomplished via a linear function. Anadditional perspective with which to view the operational adjustment isthat there can be a square-wave multiplier change.

FIG. 32 is a graphical representation 4120 of instrument systemparameter depicting how, in another aspect, a system parameter can beadjusted in the event that a threshold is reached. Time (t) is shownalong a horizontal (x) axis 4122 and the number of Instrument Operationsis shown along a vertical (y) axis 4124, marginal threshold 4126 andultimate threshold 4128. Here the y-axis 4124 parameter is the one towhich a threshold is assigned. At a certain time during operation ofinstrument 10 (FIGS. 1-4), a measurement can indicate that the marginalthreshold 4126 is reached during the course of operation 4130. At thispoint, operations of the instrument 10 can be adjusted. For example,when the y-axis 4124 parameter is electrical current draw by a motor, alimit can be placed on the subsequent current draw representing anon-linear progression 4132. At a certain time after this, an ultimatethreshold 4128 can be reached. At this point, current can bediscontinued 4134. Accordingly, an adjustment mechanism can beaccomplished via a non-linear function 4132, with a variable slope. Anadditional perspective with which to view the operational adjustment isthat there is an exponential multiplier change; here, the closer they-axis 4124 parameter comes to the ultimate threshold 4128, the rate atwhich current increases diminishes.

FIG. 33 is a graphical representation 4140 that represents one aspectwherein a response by instrument 10 (FIGS. 1-4) to clinician input (UserInput) is detected and then a modification is made. Time (t) is shownalong a horizontal (x) axis 4142 and User Input is represented along avertical (y) axis 4144. In other words, a clinician, in performing aprocedure, can actuate a response by instrument 10 such as depressingclosure trigger 32 (FIG. 1) which may for example cause motor operation4146. As motor speed increases there may or not be a threshold reached.At a certain point, however, here represented by the divergence point4148 of curves 4150 and 4152, it can be determined that motor speed hasreached an actual level, or a future level be predicted, that is or willbe suboptimal or otherwise undesirable. At this point, rather thanfollowing the actual or expected speed curve 4150, instrument 10 canemploy a control measure such as an algorithm to adapt or otherwisemodify the output, thus regulating the motor. At a certain point, motoractuation can be discontinued 4154. In other words, instrument 10 cantake an actual or expected y-axis parameter and, determining that suchactual or expected measurement is excessive, employ an algorithm tomodify such parameter. Put another way, measured clinician behavior cancomprise a value for a threshold or thresholds.

FIG. 34 is a graphical representation 4160 of instrument systemparameters that represents one aspect wherein instrument 10 (FIGS. 1-4)detects whether a marginal threshold 4166 or ultimate threshold 4168 isreached, and responds accordingly. Time (t) is shown along thehorizontal (x) axis 4162 and instrument System Parameters is shown alongthe vertical (y) axis 4164. For example, here the vertical (y) axis 4154parameter can be the velocity of a drive, such as a closure drive system30 (FIG. 1) or firing drive system 80 (FIG. 1). Instrument 10 can checkwhether during the course of operation 4170 a marginal threshold 4166velocity is reached. When the marginal threshold 4166 is reached, acontrol measure such as an algorithm can be used to adapt or otherwisemodify the velocity 4172. The modified velocity 4172 can be given by alinear or non-linear function. And, at an ultimate threshold, power tothe motor can be discontinued 4174.

It will be appreciated that where FIG. 33 can represent a situationwhere an actual or predicted value is evaluated, whether or not anexpress threshold is provided, FIG. 34 is a graphical representationwhere thresholds are provided. It can be appreciated, however, that athreshold or thresholds can be implicitly given to FIG. 33 withequivalent results, insofar as a predetermined or dynamically determinedvalue can serve as a functional equivalent of a threshold, or triggeractions associated with a threshold or thresholds. There may be two ormore ceiling or floor values that can serve as such threshold functionalequivalents.

Turning to another example using thresholds, FIG. 35 is a graphicalrepresentation 4180 of battery current versus time, where Time (t) isshown along the horizontal (x) axis 4182 and battery current I_(BAT) isshown along the vertical (y) axis 4184. In one example battery currentI_(BAT) 4184 is monitored under varying operational conditions. As motorspeed increases, current drawn 4186 from a battery 90 (FIG. 4)increases. Current drawn can increase in a non-linear manner dependingon several factors; however, instrument 10 (FIGS. 1-4) can resolve thecurrent drawn into a linear function 4188. The linear function can bebased on (1) averaging overall current, (2) be based on a prediction offuture current based on past and/or present current, both (1) and (2),or another function. Linear function 4188 can be extended outtheoretically to linear function 4190, which is an extrapolatedextension with the same slope as linear function 4188.

Once linear function 4188 reaches a marginal threshold 4192, instrument10 (FIGS. 1-4) can take action to modify the response. Here the marginalthreshold is given as 75% of an ultimate threshold 4194 wherein theultimate threshold represents a motor stall; however, it will beappreciated that the selection of the marginal threshold or ultimatethreshold can be made based on multiple factors. In other words,marginal threshold 4192 can be reached at time “a” 4196. If adjustmentsare not made, it is expected that motor stall would occur at time “b1”4198. However, due to adjustments made by instrument 10, the actualmotor stall will not occur until time “b2” 4200. It is possible that astall might not occur at all, because the more graduated rise may helpto prevent such an event. Function 4202, which is implemented via acontrol measure, can be based on slowing the motor, or anotheradjustment. It can manifest as a stepped, ramped or further function.

Employing the thresholds herein can give the clinician greater time toreact and adapt, maintain a desired efficiency of the instrument, andprolong battery life. Thus, utilizing thresholds can provide multiplebenefits in connection with ease of clinician use and protection of theinstrument itself.

Turning to another aspect, FIG. 36 is a graphical representation 4210 ofbattery voltage that shows Time (t) along the horizontal (x) axis 4212and battery voltage V_(BAT) along the vertical (y) axis 4214. In oneexample a threshold can be set in connection with battery voltageV_(BAT) 4214. Here a marginal threshold 4216 can be set at 8.1V.Additionally, an ultimate threshold 4218 can be set at 7.0V. During thecourse of operation of instrument 10 (FIGS. 1-4), voltage can decreaseover time. The curve described by measuring the voltage decrease 4220 isnot necessarily linear. However, instrument 10 can resolve the voltagedecrease into a linear function 4222. The linear function can be basedon (1) averaging overall voltage, (2) be based on a prediction of futurevoltage based on past and/or present voltage, both (1) and (2), oranother function. Linear function 4222 can be extrapolated outtheoretically to linear function 4224, which has the same slope aslinear function 4222.

Once linear function 4222 reaches a marginal threshold 4216, instrument10 can take action to modify the response. Marginal threshold 4216 isreached at time “a” 4226. If adjustments are not made, it is expectedthat a depleted battery condition would occur at time “b1” 4228.However, due to adjustments made by instrument 10 (FIGS. 1-4), theactual depleted battery condition will not occur until time “b2” 4230.Again, it is possible that it may not occur at all. Function 4232, whichcan be implemented via a control measure, can be based on slowing themotor, or another adjustment. It can manifest as a stepped, ramped orfurther function.

FIG. 37 is a graphical representation 4240 of knife speed versus numberof cycles where and Cycles is shown along the horizontal (x) axis 4242and Knife Speed is shown along the vertical (y) axis 4244. As shown inthe example illustrated by FIG. 37, thresholds can be employed to adjustspeed of a knife 280 (FIG. 8) based on the number of cycles. Relevantcycles can refer to an amount of firings performed by instrument 10(FIGS. 1-4), sterilization cycles performed by instrument 10, or othermeasured events. An objective of managing instrument operation by thisthreshold mechanism is to maximize the likelihood that an incision willbe effective, taking into account potential blunting of the knife 280edge after multiple uses. In this example, firing of the knife can beinitialized based on an expected speed. However, once a marginalthreshold 4246 is reached based on number of cycles, speed can bereduced from speed 4248 to 4252, such as in a stepped manner 4250. Thus,once marginal threshold 4760 is exceeded, knife 280 will fire at aprogressively lower speed. This will occur for a given number of cycles4246 until ultimate threshold 4254 is reached. At this point, knifespeed will be stepped down 4256 even more or of course instrument 10 canalert the clinician that it may be undesirable to incise with the knife,and can lock out firing. It will be understood that function 4248 showsemploying a stepped function once a threshold 4246 is reached, andfunction 4258 shows employing a ramped function 4260 once a threshold4246 is reached. Additional functions can be employed.

Further, it will be appreciated that the thresholds given in FIG. 37have been defined on the x-axis 4711, whereas prior figures have shownthresholds on the y-axis 4712. It will also be appreciated that therecan be an additional axis or axes taken into account, i.e., a z-axis orfurther axes, wherein the interrelationship of multiple variables can beconsidered. Further, thresholds from a first parameter can be consideredalong with thresholds from a second parameter, and one threshold cancomprise an input into another threshold, and vice versa.

When a threshold is exceeded, the clinician can be notified. This can bebased on a feedback system. In certain instances, the feedback systemmay comprise one or more visual feedback systems such as displayscreens, backlights, and/or LEDs, for example. In certain instances, thefeedback system may comprise one or more audio feedback systems such asspeakers and/or buzzers, for example. In certain instances, the feedbacksystem may comprise one or more haptic feedback systems, for example. Incertain instances, the feedback system may comprise combinations ofvisual, audio, and/or tactile feedback systems, for example. Suchfeedback can serve to alert or warn the clinician.

FIG. 38 illustrates a logic diagram of a system 4311 for evaluatingsharpness of a cutting edge 182 (FIG. 20) of a surgical instrument 10(FIGS. 1-4) according to various examples. FIG. 38 illustrates asharpness testing system 4311 for evaluating sharpness of a cutting edgeof a surgical instrument 10 according to various examples. In certaininstances, the system 4311 can evaluate the sharpness of the cuttingedge 182 by testing the ability of the cutting edge 182 to be advancedthrough a sharpness testing member 4302. For example, the system 4311can be configured to observe the time period the cutting edge 182 takesto fully transect and/or completely pass through at least apredetermined portion of a sharpness testing member 4302. If theobserved time period exceeds a predetermined threshold, the module 4310may conclude that the sharpness of the cutting edge 182 has droppedbelow an acceptable level, for example.

In one aspect, the sharpness testing member 4302 can be employed to testthe sharpness of the cutting edge 182 (FIG. 20). In certain instances,the sharpness testing member 4302 can be attached to and/or integratedwith the cartridge body 194 (FIG. 20) of the staple cartridge 304 (FIGS.1, 2, and 20), for example. In certain instances, the sharpness testingmember 4302 can be disposed in the proximal portion of the staplecartridge 304, for example. In certain instances, the sharpness testingmember 4302 can be disposed onto a cartridge deck or cartridge body 194of the staple cartridge 304, for example.

In certain instances, a load cell 4335 can be configured to monitor theforce (Fx) applied to the cutting edge 182 (FIG. 20) while the cuttingedge 182 is engaged and/or in contact with the sharpness testing member4302, for example. The reader will appreciate that the force (Fx)applied by the sharpness testing member 4302 to the cutting edge 182while the cutting edge 182 is engaged and/or in contact with thesharpness testing member 4302 may depend, at least in part, on thesharpness of the cutting edge 182. In certain instances, a decrease inthe sharpness of the cutting edge 182 can result in an increase in theforce (Fx) required for the cutting edge 182 to cut or pass through thesharpness testing member 4302. The load cell 4335 of the sharpnesstesting member 4302 may be employed to measure the force (Fx) applied tothe cutting edge 182 while the cutting edge 182 travels a predefineddistance (D) through the sharpness testing member 4302 may be employedto determine the sharpness of the cutting edge 182.

In certain instances, the module 4311 may include a microcontroller 4313(“controller”) which may include a microprocessor 4315 (“processor”) andone or more computer readable mediums or memory units 4317 (“memory”).In certain instances, the memory 4317 may store various programinstructions, which when executed may cause the processor 4315 toperform a plurality of functions and/or calculations described herein.In certain instances, the memory 4317 may be coupled to the processor4315, for example. A power source 4319 can be configured to supply powerto the controller 4313, for example. In certain instances, the powersource 4319 may comprise a battery (or “battery pack” or “power pack”),such as a Li ion battery, for example. In certain instances, the batterypack may be configured to be releasably mounted to the handle 14. Anumber of battery cells connected in series may be used as the powersource 4319. In certain instances, the power source 4319 may bereplaceable and/or rechargeable, for example.

In certain instances, the processor 4313 can be operably coupled to thefeedback system and/or the lockout mechanism 4123, for example.

The module 4311 may comprise one or more position sensors. Exampleposition sensors and positioning systems suitable for use with thepresent disclosure are described in U.S. patent application Ser. No.13/803,210, entitled SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEMFOR SURGICAL INSTRUMENTS, and filed Mar. 14, 2013, now U.S. PatentApplication Publication No. 2014/0263538, the disclosure of which ishereby incorporated by reference herein in its entirety. In certaininstances, the module 4311 may include a first position sensor 4321 anda second position sensor 4323. In certain instances, the first positionsensor 4321 can be employed to detect a first position of the cuttingedge 182 (FIG. 20) at a proximal end of a sharpness testing member 4302,for example; and the second position sensor 4323 can be employed todetect a second position of the cutting edge 182 at a distal end of asharpness testing member 4302, for example.

In certain instances, the position sensors 4321 and 4323 can be employedto provide first and second position signals, respectively, to themicrocontroller 4313. It will be appreciated that the position signalsmay be analog signals or digital values based on the interface betweenthe microcontroller 4313 and the position sensors 4321 and 4323. In oneexample, the interface between the microcontroller 4313 and the positionsensors 4321 and 4323 can be a standard serial peripheral interface(SPI), and the position signals can be digital values representing thefirst and second positions of the cutting edge 182, as described above.

Further to the above, the processor 4315 may determine the time periodbetween receiving the first position signal and receiving the secondposition signal. The determined time period may correspond to the timeit takes the cutting edge 182 (FIG. 20) to advance through a sharpnesstesting member 4302 from the first position at a proximal end of thesharpness testing member 4302, for example, to a second position at adistal end of the sharpness testing member 4302, for example. In atleast one example, the controller 4313 may include a time element whichcan be activated by the processor 4315 upon receipt of the firstposition signal, and deactivated upon receipt of the second positionsignal. The time period between the activation and deactivation of thetime element may correspond to the time it takes the cutting edge 182 toadvance from the first position to the second position, for example. Thetime element may comprise a real time clock, a processor configured toimplement a time function, or any other suitable timing circuit.

In various instances, the controller 4313 can compare the time period ittakes the cutting edge 182 (FIG. 20) to advance from the first positionto the second position to a predefined threshold value to assess whetherthe sharpness of the cutting edge 182 has dropped below an acceptablelevel, for example. In certain instances, the controller 4313 mayconclude that the sharpness of the cutting edge 182 has dropped below anacceptable level if the measured time period exceeds the predefinedthreshold value by 1%, 5%, 10%, 25%, 50%, 100% and/or more than 100%,for example.

FIG. 39 illustrates a logic diagram of a system 4340 for determining theforces applied against a cutting edge of a surgical instrument 10 (FIGS.1-4) by a sharpness testing member 4302 at various sharpness levelsaccording to various aspects. Referring to FIG. 39, in variousinstances, an electric motor 4331 can drive the firing bar 172 (FIG. 20)to advance the cutting edge 182 (FIG. 20) during a firing stroke and/orto retract the cutting edge 182 during a return stroke, for example. Amotor driver 4333 can control the electric motor 4331; and amicrocontroller such as, for example, the microcontroller 4313 can be insignal communication with the motor driver 4333. As the electric motor4331 advances the cutting edge 182, the microcontroller 4313 candetermine the current drawn by the electric motor 4331, for example. Insuch instances, the force required to advance the cutting edge 182 cancorrespond to the current drawn by the electric motor 4331, for example.Referring still to FIG. 39, the microcontroller 4313 of the surgicalinstrument 10 can determine if the current drawn by the electric motor4331 increases during advancement of the cutting edge 182 and, if so,can calculate the percentage increase of the current.

In certain instances, the current drawn by the electric motor 4331 mayincrease significantly while the cutting edge 182 (FIG. 20) is incontact with the sharpness testing member 4302 due to the resistance ofthe sharpness testing member 4302 to the cutting edge 182. For example,the current drawn by the electric motor 4331 may increase significantlyas the cutting edge 182 engages, passes and/or cuts through thesharpness testing member 4302. The reader will appreciate that theresistance of the sharpness testing member 4302 to the cutting edge 182depends, in part, on the sharpness of the cutting edge 182; and as thesharpness of the cutting edge 182 decreases from repetitive use, theresistance of the sharpness testing member 4302 to the cutting edge 182will increase. Accordingly, the value of the percentage increase of thecurrent drawn by the motor 4331 while the cutting edge is in contactwith the sharpness testing member 4302 can increase as the sharpness ofthe cutting edge 182 decreases from repetitive use, for example.

In certain instances, the determined value of the percentage increase ofthe current drawn by the motor 4331 can be the maximum detectedpercentage increase of the current drawn by the motor 4331. In variousinstances, the microcontroller 4313 can compare the determined value ofthe percentage increase of the current drawn by the motor 4331 to apredefined threshold value of the percentage increase of the currentdrawn by the motor 4331. If the determined value exceeds the predefinedthreshold value, the microcontroller 4313 may conclude that thesharpness of the cutting edge 182 has dropped below an acceptable level,for example.

In certain instances, as illustrated in FIG. 39, the processor 4315 canbe in communication with the feedback system and/or the lockoutmechanism for example. In certain instances, the processor 4315 canemploy the feedback system to alert a user if the determined value ofthe percentage increase of the current drawn by the motor 4331 exceedsthe predefined threshold value, for example. In certain instances, theprocessor 4315 may employ the lockout mechanism to prevent advancementof the cutting edge 182 (FIG. 20) if the determined value of thepercentage increase of the current drawn by the motor 4331 exceeds thepredefined threshold value, for example. In certain instances, thesystem 4311 may include a first position sensor 4321 and a secondposition sensor 4323. The surgical instrument 10 (FIGS. 1-4) may includea load cell 4335.

In various instances, the microcontroller 4313 can utilize an algorithmto determine the change in current drawn by the electric motor 4331. Forexample, a current sensor can detect the current drawn by the electricmotor 4331 during the firing stroke. The current sensor can continuallydetect the current drawn by the electric motor and/or can intermittentlydetect the current draw by the electric motor. In various instances, thealgorithm can compare the most recent current reading to the immediatelyproceeding current reading, for example. Additionally or alternatively,the algorithm can compare a sample reading within a time period X to aprevious current reading. For example, the algorithm can compare thesample reading to a previous sample reading within a previous timeperiod X, such as the immediately proceeding time period X, for example.In other instances, the algorithm can calculate the trending average ofcurrent drawn by the motor. The algorithm can calculate the averagecurrent draw during a time period X that includes the most recentcurrent reading, for example, and can compare that average current drawto the average current draw during an immediately proceeding time periodtime X, for example.

FIG. 40 illustrates a logic diagram 4350 of a method for determiningwhether a cutting edge of a surgical instrument 10 (FIGS. 1-4) issufficiently sharp to transect tissue captured by the surgicalinstrument 10 according to various aspects. Referring to FIG. 40, thelogic diagram 4350 depicts a method for evaluating the sharpness of thecutting edge 182 (FIG. 20) of the surgical instrument 10; and variousresponses are outlined in the event the sharpness of the cutting edge182 drops to and/or below an alert threshold and/or a high severitythreshold, for example. In various instances, a microcontroller such as,for example, the microcontroller 4313 can be configured to implement themethod 4350 depicted in FIG. 40. In certain instances, the surgicalinstrument 10 may include a load cell 4335, as illustrated in FIGS. 38and 39, and the microcontroller 4313 may be in communication with theload cell 4335. In certain instances, the load cell 4335 may include aforce sensor such as, for example, a strain gauge, which can be operablycoupled to the firing bar 172, for example. In certain instances, themicrocontroller 4313 may employ the load cell 4335 to monitor the force(Fx) applied to the cutting edge 182 as the cutting edge 182 is advancedduring a firing stroke.

In various instances, the method 4350 begins by initiating 4352 firingof the surgical instrument 10 (FIGS. 1-4). Before, during, and/or afterfiring of the surgical instrument 10 is initiated 4352, a system checks4354 the dullness of the cutting edge 182 by monitoring a force (Fx).The reader will appreciate that the force (Fx) is applied by thesharpness testing member 4302 to the cutting edge 182 while the cuttingedge 182 is engaged and/or in contact with the sharpness testing member4302, and, the force (Fx) may depend, at least in part, on the sharpnessof the cutting edge 182. In certain instances, a decrease in thesharpness of the cutting edge 182 can result in an increase in the force(Fx) required for the cutting edge 182 to cut or pass through thesharpness testing member 4302.

The system senses 4356 the force (Fx) applied by the sharpness testingmember 4302 to the cutting edge 182 (FIG. 20). When the force (Fx)sensed 4356 stays within an alert threshold range a display will display4358 nothing and firing 4360 of the surgical instrument 10 (FIGS. 1-4)will proceed. When the force (Fx) sensed 4356 is outside the alertthreshold range, the system 4354 will then determine if the force (Fx)is outside a high severity threshold range. The display will display4364 an alert to the user of the surgical instrument 10 that the cuttingedge 182 is dulling. At this stage, the user is aware that the cuttingedge 182 is dulling and may need replaced. When the force (Fx) is sensed4362 to be greater than the high severity threshold range, the displaydisplays 4366 a warning indicating the force (Fx) applied to the cuttingedge 182 is greater than the high severity threshold and that thecutting edge 182 is dull. If the cutting edge is determined to be dull,a firing lockout system may be engaged. The display may display 4368 anoptional display sequence to allow the user of the surgical instrument10 to override the firing lockout system and continue firing 4360 thissurgical instrument 10.

In certain instances, the load cell 4335 (FIGS. 38, 39) can beconfigured to monitor the force (Fx) applied to the cutting edge 182(FIG. 20) while the cutting edge 182 is engaged and/or in contact withthe sharpness testing member 4302 (FIGS. 38, 39), for example. Thereader will appreciate that the force (Fx) applied by the sharpnesstesting member 4302 to the cutting edge 182 while the cutting edge 182is engaged and/or in contact with the sharpness testing member 4302 maydepend, at least in part, on the sharpness of the cutting edge 182. Incertain instances, a decrease in the sharpness of the cutting edge 182can result in an increase in the force (Fx) required for the cuttingedge 182 to cut or pass through the sharpness testing member 4302. Forexample, as illustrated graphically in FIG. 41, graphs 4336, 4338, and4342 represent, respectively, the force (Fx) applied to the cutting edge182 while the cutting edge 182 travels a predefined distance (D) throughthree identical, or at least substantially identical, sharpness testingmembers 4302. The graph 4336 corresponds to a first sharpness of thecutting edge 182; the graph 4338 corresponds to a second sharpness ofthe cutting edge 182; and the graph 4342 corresponds to a thirdsharpness of the cutting edge 182. The first sharpness is greater thanthe second sharpness, and the second sharpness is greater than the thirdsharpness.

In certain instances, the microcontroller 4313 (FIGS. 38, 39) maycompare a maximum value of the monitored force (Fx) applied to thecutting edge 182 (FIG. 20) to one or more predefined threshold values.In certain instances, as illustrated in FIG. 41, the predefinedthreshold values may include an alert threshold (F1) and/or a highseverity threshold (F2). In certain instances, as illustrated in thegraph 4336 of FIG. 41, the monitored force (Fx) can be less than thealert threshold (F1), for example. In such instances, as illustrated inFIG. 41, the sharpness of the cutting edge 182 is at a good level andthe microcontroller 4313 may take no action to alert a user as to thestatus of the cutting edge 182 or may inform the user that the sharpnessof the cutting edge 182 is within an acceptable range.

In certain instances, as illustrated in the graph 4338 of FIG. 41, themonitored force (Fx) can be more than the alert threshold (F1) but lessthan the high severity threshold (F2), for example. In such instances,as illustrated in FIG. 40, the sharpness of the cutting edge 182 (FIG.2) can be dulling but still within an acceptable level. Themicrocontroller 4313 may take no action to alert a user as to the statusof the cutting edge 182. Alternatively, the microcontroller 4313 (FIGS.38, 39) may inform the user that the sharpness of the cutting edge 182is within an acceptable range. Alternatively or additionally, themicrocontroller 4313 may determine or estimate the number of cuttingcycles remaining in the lifecycle of the cutting edge 182 and may alertthe user accordingly.

In certain instances, the memory 4317 (FIGS. 38, 39) may include adatabase or a table that correlates the number of cutting cyclesremaining in the lifecycle of the cutting edge 182 (FIG. 20) topredetermined values of the monitored force (Fx). The processor 4315(FIGS. 38, 39) may access the memory 4317 to determine the number ofcutting cycles remaining in the lifecycle of the cutting edge 182 whichcorrespond to a particular measured value of the monitored force (Fx)and may alert the user to the number of cutting cycles remaining in thelifecycle of the cutting edge 182, for example.

In certain instances, as illustrated in the graph 4342 of FIG. 41, themonitored force (Fx) can be more than the high severity threshold (F2),for example. In such instances, as illustrated in FIG. 40, the sharpnessof the cutting edge 182 can be below an acceptable level. In response,the microcontroller 4313 may employ the feedback system to warn the userthat the cutting edge 182 is too dull for safe use, for example. Incertain instances, the microcontroller 4313 may employ the lockoutmechanism to prevent advancement of the cutting edge 182 upon detectionthat the monitored force (Fx) exceeds the high severity threshold (F2),for example. In certain instances, the microcontroller 4313 may employthe feedback system to provide instructions to the user for overridingthe lockout mechanism, for example.

Referring now to FIG. 42, a method 4370 is depicted for determiningwhether a cutting edge such as, for example, the cutting edge 182 (FIG.20) is sufficiently sharp to be employed in transecting a tissue of aparticular tissue thickness that is captured by the end effector 300(FIG. 1), for example. In certain instances, the microcontroller 4313can be implemented to perform the method 4370 depicted in FIG. 42, forexample. As described above, repetitive use of the cutting edge 182 maydull or reduce the sharpness of the cutting edge 182 which may increasethe force required for the cutting edge 182 to transect the capturedtissue. In other words, the sharpness level of the cutting edge 182 canbe defined by the force required for the cutting edge 182 to transectthe captured tissue, for example. The reader will appreciate that theforce required for the cutting edge 182 to transect a captured tissuealso may depend on the thickness of the captured tissue. In certaininstances, the greater the thickness of the captured tissue, the greaterthe force required for the cutting edge 182 to transect the capturedtissue at the same sharpness level, for example.

In certain instances, the cutting edge 182 (FIG. 20) may be sufficientlysharp for transecting a captured tissue comprising a first thickness butmay not be sufficiently sharp for transecting a captured tissuecomprising a second thickness greater than the first thickness, forexample. In certain instances, a sharpness level of the cutting edge182, as defined by the force required for the cutting edge 182 totransect a captured tissue, may be adequate for transecting the capturedtissue if the captured tissue comprises a tissue thickness that is in aparticular range of tissue thicknesses, for example. In certaininstances, the memory 4317 (FIGS. 38, 39) can store one or morepredefined ranges of tissue thicknesses of tissue captured by the endeffector 300; and predefined threshold forces associated with thepredefined ranges of tissue thicknesses. In certain instances, eachpredefined threshold force may represent a minimum sharpness level ofthe cutting edge 182 that is suitable for transecting a captured tissuecomprising a tissue thickness (Tx) encompassed by the range of tissuethicknesses that is associated with the predefined threshold force. Incertain instances, when the force (Fx) required for the cutting edge 182to transect the captured tissue, comprising the tissue thickness (Tx),exceeds the predefined threshold force associated with the predefinedrange of tissue thicknesses that encompasses the tissue thickness (Tx),the cutting edge 182 may not be sufficiently sharp to transect thecaptured tissue, for example.

The method 4370 shown in FIG. 42 begins with clamping 4372 the tissue.Once the tissue to be transected is clamped, the thickness of the tissueis sensed 4374. After the tissue thickness is sensed 4374, firing of thesurgical instrument can be initiated 4376 by the user. Once the surgicalinstrument begins firing, the force (Fx) applied to the cutting edge 182(FIG. 20) is sensed 4378. The force (Fx) and the tissue thickness (Tx)is then compared 4380 to predetermined tissue thickness ranges and forceranges required to adequately transect the predetermined tissuethicknesses. For example, if the force (Fx) sensed is greater than apredetermined force range required to adequately transect tissue at thetissue thickness (Tx) that was sensed for the tissue clamped, a displaywill display 4386 an alert to the user that the cutting edge 182 isdulling. When the force (Fx) sensed is within the predetermined forcerange required to adequately transect tissue at the tissue thickness(Tx) that was sensed for the tissue clamped, the display may display4382 nothing. In both instances, the surgical instrument continues 4384firing to transect the tissue.

The present disclosure will now be described in connection with variousexamples and combinations of such examples as set forth hereinbelow.

1. One example provides a surgical cutting and stapling instrumentcomprising at least one processor and operatively associated memory, theinstrument configured to: identify a parameter; identify a value of anultimate threshold for the parameter; and identify a value of a marginalthreshold for the parameter.

2. Another example provides the instrument of example 1, whereinoperations of the instrument are adjusted based on a determination thata measured value of the parameter exceeds the value of the ultimatethreshold.

3. Another example provides the instrument of examples 1 or 2, whereinoperations of the instrument are adjusted based on a determination thata measured value of the parameter exceeds the value of the marginalthreshold.

4. Another example provides the instrument of examples 1, 2, or 3,wherein a modified rate of change of the value of the parameter iscalculated based on a determination that a predicted rate of change ofthe value of the parameter will result in a value that will exceed thevalue of the ultimate threshold.

5. Another example provides the instrument of example 4, whereinoperations of the instrument are adjusted based on the calculatedmodified rate of change of the parameter.

6. Another example provides the instrument of example 5, wherein theadjustment is based on a stepped function.

7. Another example provides the instrument of example 5, wherein theadjustment is based on a ramped function.

8. Another example provides the instrument of example 5, wherein thevalue of the calculated rate of change comprises a set of values locatedbetween the value of the marginal threshold and the value of theultimate threshold.

9. Another example provides the instrument of any one of examples 1-8,wherein the value of the marginal threshold is approximately 75% of thevalue of the ultimate threshold.

10. Another example provides the instrument of any one of examples 1-9,wherein the parameter comprises current drawn by a battery associatedwith the instrument.

11. Another example provides the instrument of any one of examples 1-10,wherein the parameter comprises voltage of a battery associated with theinstrument.

12. Another example provides the instrument of any of example 1-11,wherein the parameter comprises speed of a knife fired by theinstrument.

13. Another example provides the instrument of any one of claims 1-12,wherein the parameter comprises a number of sterilization cyclesassociated with the surgical instrument.

14. Another example provide the instrument of any one of examples 1-13,wherein the parameter comprises a measured behavior of a clinicianduring operation of the instrument.

15. Yet another example, provides a surgical cutting and staplinginstrument comprising at least one processor and operatively associatedmemory, the surgical instrument configured to: identify a firstparameter; identify a second parameter; and identify a specifiedthreshold, the specified threshold comprising one or more of: a value ofan ultimate threshold for the first parameter; a value of a marginalthreshold for the first parameter; a value of an ultimate threshold forthe second parameter; and a value of a marginal threshold for the secondparameter.

16. Another example provides the instrument of example 15, furtherconfigured to adjust operations upon a determination that a specifiedthreshold has been exceeded.

17. Another example provides the instrument of example 15 or 16, furtherconfigured to store an overlaying threshold, the overlaying thresholdbased on a mathematical relationship between, on one hand, the value ofthe first ultimate threshold or the value of the first marginalthreshold, and, on the other hand, the value of the second ultimatethreshold or the value of the second marginal threshold.

18. Another example provide the instrument of any one of examples 15-17,wherein the first parameter comprises speed of a motor of theinstrument, and the second parameter comprises a number of sterilizationcycles of the instrument.

19. Another example provides the instrument of any one of examples15-18, wherein the first parameter comprises a speed of a knife deployedby the instrument, and the second parameter is a number of sterilizationcycles of the instrument.

20. Another example provides the instrument of any one of examples15-19, wherein a third threshold is identified based on a determinationthat the instrument has exceeded a value of a specified threshold.

In accordance with various examples, the surgical instruments describedherein may comprise one or more processors (e.g., microprocessor,microcontroller) coupled to various sensors. In addition, to theprocessor(s), a storage (having operating logic) and communicationinterface, are coupled to each other.

As described earlier, the sensors may be configured to detect andcollect data associated with the surgical device. The processorprocesses the sensor data received from the sensor(s).

The processor may be configured to execute the operating logic. Theprocessor may be any one of a number of single or multi-core processorsknown in the art. The storage may comprise volatile and non-volatilestorage media configured to store persistent and temporal (working) copyof the operating logic.

In various aspects, the operating logic may be configured to perform theinitial processing, and transmit the data to the computer hosting theapplication to determine and generate instructions. For these examples,the operating logic may be further configured to receive informationfrom and provide feedback to a hosting computer. In alternate examples,the operating logic may be configured to assume a larger role inreceiving information and determining the feedback. In either case,whether determined on its own or responsive to instructions from ahosting computer, the operating logic may be further configured tocontrol and provide feedback to the user.

In various aspects, the operating logic may be implemented ininstructions supported by the instruction set architecture (ISA) of theprocessor, or in higher level languages and compiled into the supportedISA. The operating logic may comprise one or more logic units ormodules. The operating logic may be implemented in an object orientedmanner. The operating logic may be configured to be executed in amulti-tasking and/or multi-thread manner. In other examples, theoperating logic may be implemented in hardware such as a gate array.

In various aspects, the communication interface may be configured tofacilitate communication between a peripheral device and the computingsystem. The communication may include transmission of the collectedbiometric data associated with position, posture, and/or movement dataof the user's body part(s) to a hosting computer, and transmission ofdata associated with the tactile feedback from the host computer to theperipheral device. In various examples, the communication interface maybe a wired or a wireless communication interface. An example of a wiredcommunication interface may include, but is not limited to, a UniversalSerial Bus (USB) interface. An example of a wireless communicationinterface may include, but is not limited to, a Bluetooth interface.

For various aspects, the processor may be packaged together with theoperating logic. In various examples, the processor may be packagedtogether with the operating logic to form a SiP. In various examples,the processor may be integrated on the same die with the operatinglogic. In various examples, the processor may be packaged together withthe operating logic to form a System on Chip (SoC).

Various aspects may be described herein in the general context ofcomputer executable instructions, such as software, program modules,and/or engines being executed by a processor. Generally, software,program modules, and/or engines include any software element arranged toperform particular operations or implement particular abstract datatypes. Software, program modules, and/or engines can include routines,programs, objects, components, data structures and the like that performparticular tasks or implement particular abstract data types. Animplementation of the software, program modules, and/or enginescomponents and techniques may be stored on and/or transmitted acrosssome form of computer-readable media. In this regard, computer-readablemedia can be any available medium or media useable to store informationand accessible by a computing device. Some examples also may bepracticed in distributed computing environments where operations areperformed by one or more remote processing devices that are linkedthrough a communications network. In a distributed computingenvironment, software, program modules, and/or engines may be located inboth local and remote computer storage media including memory storagedevices. A memory such as a random access memory (RAM) or other dynamicstorage device may be employed for storing information and instructionsto be executed by the processor. The memory also may be used for storingtemporary variables or other intermediate information during executionof instructions to be executed by the processor.

Although some aspects may be illustrated and described as comprisingfunctional components, software, engines, and/or modules performingvarious operations, it can be appreciated that such components ormodules may be implemented by one or more hardware components, softwarecomponents, and/or combination thereof. The functional components,software, engines, and/or modules may be implemented, for example, bylogic (e.g., instructions, data, and/or code) to be executed by a logicdevice (e.g., processor). Such logic may be stored internally orexternally to a logic device on one or more types of computer-readablestorage media. In other examples, the functional components such assoftware, engines, and/or modules may be implemented by hardwareelements that may include processors, microprocessors, circuits, circuitelements (e.g., transistors, resistors, capacitors, inductors, and soforth), integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates,registers, semiconductor device, chips, microchips, chip sets, and soforth.

Examples of software, engines, and/or modules may include softwarecomponents, programs, applications, computer programs, applicationprograms, system programs, machine programs, operating system software,middleware, firmware, software modules, routines, subroutines,functions, methods, procedures, software interfaces, application programinterfaces (API), instruction sets, computing code, computer code, codesegments, computer code segments, words, values, symbols, or anycombination thereof. Determining whether one example is implementedusing hardware elements and/or software elements may vary in accordancewith any number of factors, such as desired computational rate, powerlevels, heat tolerances, processing cycle budget, input data rates,output data rates, memory resources, data bus speeds and other design orperformance constraints.

One or more of the modules described herein may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. One or more of the modules described herein maycomprise various executable modules such as software, programs, data,drivers, application APIs, and so forth. The firmware may be stored in amemory of the controller and/or the controller which may comprise anonvolatile memory (NVM), such as in bit-masked ROM or flash memory. Invarious implementations, storing the firmware in ROM may preserve flashmemory. The NVM may comprise other types of memory including, forexample, programmable ROM (PROM), erasable programmable ROM (EPROM),EEPROM, or battery backed RAM such as dynamic RAM (DRAM),Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

In some cases, various aspects may be implemented as an article ofmanufacture. The article of manufacture may include a computer readablestorage medium arranged to store logic, instructions and/or data forperforming various operations of one or more examples. In variousexamples, for example, the article of manufacture may comprise amagnetic disk, optical disk, flash memory or firmware containingcomputer program instructions suitable for execution by a generalpurpose processor or application specific processor. The examples,however, are not limited in this context.

The functions of the various functional elements, logical blocks,modules, and circuits elements described in connection with the examplesdisclosed herein may be implemented in the general context of computerexecutable instructions, such as software, control modules, logic,and/or logic modules executed by the processing unit. Generally,software, control modules, logic, and/or logic modules comprise anysoftware element arranged to perform particular operations. Software,control modules, logic, and/or logic modules can comprise routines,programs, objects, components, data structures and the like that performparticular tasks or implement particular abstract data types. Animplementation of the software, control modules, logic, and/or logicmodules and techniques may be stored on and/or transmitted across someform of computer-readable media. In this regard, computer-readable mediacan be any available medium or media useable to store information andaccessible by a computing device. Some examples also may be practiced indistributed computing environments where operations are performed by oneor more remote processing devices that are linked through acommunications network. In a distributed computing environment,software, control modules, logic, and/or logic modules may be located inboth local and remote computer storage media including memory storagedevices.

Additionally, it is to be appreciated that the aspects described hereinillustrate example implementations, and that the functional elements,logical blocks, modules, and circuits elements may be implemented invarious other ways which are consistent with the described examples.Furthermore, the operations performed by such functional elements,logical blocks, modules, and circuits elements may be combined and/orseparated for a given implementation and may be performed by a greaternumber or fewer number of components or modules. As will be apparent tothose of skill in the art upon reading the present disclosure, each ofthe individual examples described and illustrated herein has discretecomponents and features which may be readily separated from or combinedwith the features of any of the other several aspects without departingfrom the scope of the present disclosure. Any recited method can becarried out in the order of events recited or in any other order whichis logically possible.

It is worthy to note that any reference to “one example” or “an example”means that a particular feature, structure, or characteristic describedin connection with the example is comprised in at least one example. Theappearances of the phrase “in one example” or “in one aspect” in thespecification are not necessarily all referring to the same example.

Unless specifically stated otherwise, it may be appreciated that termssuch as “processing,” “computing,” “calculating,” “determining,” or thelike, refer to the action and/or processes of a computer or computingsystem, or similar electronic computing device, such as a generalpurpose processor, a DSP, ASIC, FPGA or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described hereinthat manipulates and/or transforms data represented as physicalquantities (e.g., electronic) within registers and/or memories intoother data similarly represented as physical quantities within thememories, registers or other such information storage, transmission ordisplay devices.

It is worthy to note that some aspects may be described using theexpression “coupled” and “connected” along with their derivatives. Theseterms are not intended as synonyms for each other. For example, someaspects may be described using the terms “connected” and/or “coupled” toindicate that two or more elements are in direct physical or electricalcontact with each other. The term “coupled,” however, also may mean thattwo or more elements are not in direct contact with each other, but yetstill co-operate or interact with each other. With respect to softwareelements, for example, the term “coupled” may refer to interfaces,message interfaces, API, exchanging messages, and so forth.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

The present disclosure applies to conventional endoscopic and opensurgical instrumentation as well as application in robotic-assistedsurgery.

Aspects of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Examples may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, examples of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, examples of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, aspects described herein may be processed beforesurgery. First, a new or used instrument may be obtained and whennecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device also may be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, plasma peroxide, or steam.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely examples and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically matable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

Some aspects may be described using the expression “coupled” and“connected” along with their derivatives. It should be understood thatthese terms are not intended as synonyms for each other. For example,some aspects may be described using the term “connected” to indicatethat two or more elements are in direct physical or electrical contactwith each other. In another example, some aspects may be described usingthe term “coupled” to indicate that two or more elements are in directphysical or electrical contact. The term “coupled,” however, also maymean that two or more elements are not in direct contact with eachother, but yet still co-operate or interact with each other.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true scope of the subject matter described herein. It will beunderstood by those within the art that, in general, terms used herein,and especially in the appended claims (e.g., bodies of the appendedclaims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that when aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even when a specific number of an introduced claimrecitation is explicitly recited, those skilled in the art willrecognize that such recitation should typically be interpreted to meanat least the recited number (e.g., the bare recitation of “tworecitations,” without other modifiers, typically means at least tworecitations, or two or more recitations). Furthermore, in thoseinstances where a convention analogous to “at least one of A, B, and C,etc.” is used, in general such a construction is intended in the senseone having skill in the art would understand the convention (e.g., “asystem having at least one of A, B, and C” would include but not belimited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, or C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). It will be further understood by those withinthe art that typically a disjunctive word and/or phrase presenting twoor more alternative terms, whether in the description, claims, ordrawings, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms unlesscontext dictates otherwise. For example, the phrase “A or B” will betypically understood to include the possibilities of “A” or “B” or “Aand B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

What is claimed is:
 1. A surgical cutting and stapling instrumentcomprising at least one processor and operatively associated memory, theinstrument configured to: identify a parameter; identify a value of anultimate threshold for the parameter; and identify a value of a marginalthreshold for the parameter.
 2. The instrument of claim 1, whereinoperations of the instrument are adjusted based on a determination thata measured value of the parameter exceeds the value of the ultimatethreshold.
 3. The instrument of claim 1, wherein operations of theinstrument are adjusted based on a determination that a measured valueof the parameter exceeds the value of the marginal threshold.
 4. Theinstrument of claim 1, wherein a modified rate of change of the value ofthe parameter is calculated based on a determination that a predictedrate of change of the value of the parameter will result in a value thatwill exceed the value of the ultimate threshold.
 5. The instrument ofclaim 4, wherein operations of the instrument are adjusted based on thecalculated modified rate of change of the parameter.
 6. The instrumentof claim 5, wherein the adjustment is based on a stepped function. 7.The instrument of claim 5, wherein the adjustment is based on a rampedfunction.
 8. The instrument of claim 5, wherein the value of thecalculated rate of change comprises a set of values located between thevalue of the marginal threshold and the value of the ultimate threshold.9. The instrument of claim 1, wherein the value of the marginalthreshold is approximately 75% of the value of the ultimate threshold.10. The instrument of claim 1, wherein the parameter comprises currentdrawn by a battery associated with the instrument.
 11. The instrument ofclaim 1, wherein the parameter comprises voltage of a battery associatedwith the instrument.
 12. The instrument of claim 1, wherein theparameter comprises speed of a knife fired by the instrument.
 13. Theinstrument of claim 1, wherein the parameter comprises a number ofsterilization cycles associated with the surgical instrument.
 14. Theinstrument of claim 1, wherein the parameter comprises a measuredbehavior of a clinician during operation of the instrument.
 15. Asurgical cutting and stapling instrument comprising at least oneprocessor and operatively associated memory, the surgical instrumentconfigured to: identify a first parameter; identify a second parameter;and identify a specified threshold, the specified threshold comprisingone or more of: a value of an ultimate threshold for the firstparameter; a value of a marginal threshold for the first parameter; avalue of an ultimate threshold for the second parameter; and a value ofa marginal threshold for the second parameter.
 16. The instrument ofclaim 15, further configured to adjust operations upon a determinationthat a specified threshold has been exceeded.
 17. The instrument ofclaim 15, further configured to store an overlaying threshold, theoverlaying threshold based on a mathematical relationship between, onone hand, the value of the first ultimate threshold or the value of thefirst marginal threshold, and, on the other hand, the value of thesecond ultimate threshold or the value of the second marginal threshold.18. The instrument of claim 15 wherein the first parameter comprisesspeed of a motor of the instrument, and the second parameter comprises anumber of sterilization cycles of the instrument.
 19. The instrument ofclaim 15 wherein the first parameter comprises a speed of a knifedeployed by the instrument, and the second parameter is a number ofsterilization cycles of the instrument.
 20. The instrument of claim 15,wherein a third threshold is identified based on a determination thatthe instrument has exceeded a value of a specified threshold.